National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/20257

TDMS Study 99022-02 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                      AZT TRANSPLACENTAL CARCINOGENESIS STUDY                       DATE: 09/09/04       
EXPERIMENT: 99022 TEST: 02                                                                                     TIME: 14:02:01       
TEST TYPE:  PERINATAL EXPOS                     CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-15328                              ROUTE: IN-UTERO                                                NTP C#: C99022       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 30516-87-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                     FINAL #2; REVISION #1 MICE                                                     
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       MERGE   001   001,011                    0       MG/KG/DY                                    
                                       MERGE   002   002,012                    50      MG/KG/DY                                    
                                       MERGE   003   003,013                    100     MG/KG/DY                                    
                                       MERGE   004   004,014                    200     MG/KG/DY                                    
                                       MERGE   005   005,015                    300     MG/KG/DY                                    
                                       MERGE   006   006,016                    0       MG/KG/DY                                    
                                       MERGE   007   007,017                    50      MG/KG/DY                                    
                                       MERGE   008   008,018                    100     MG/KG/DY                                    
                                       MERGE   009   009,019                    200     MG/KG/DY                                    
                                       MERGE   010   010,020                    300     MG/KG/DY                                    
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                      AZT TRANSPLACENTAL CARCINOGENESIS STUDY                       DATE: 09/09/04       
EXPERIMENT: 99022 TEST: 02                                                                                     TIME: 14:02:01       
TEST TYPE:  PERINATAL EXPOS                     CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-15328                              ROUTE: IN-UTERO                                                NTP C#: C99022       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 30516-87-1      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF         AZT TRANSPLACENTAL CARCINOGENESIS                                                                        
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Bone Marrow                            Hyperplasia                                                                                  
Bone: Femur                            Osteopetrosis                                                                                
Heart                                  Cardiomyopathy                                                                               
Intestine Large, Cecum                 Edema                                                                                        
Kidney                                 Amyloid Deposition                                                                           
                                       Cyst                                                                                         
                                       Hydronephrosis                                                                               
                                       Infiltration Cellular Mixed Cell                                                             
                                       Inflammation                                                                                 
                                       Nephropathy                                                                                  
Kidney: Renal Tubule                   Dilatation                                                                                   
Liver                                  Infiltration Cellular Mixed Cell                                                             
Liver: Hepatocyte                      Hypertrophy                                                                                  
Lung                                   Edema                                                                                        
                                       Infiltration Cellular Histiocyte                                                             
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
Lymph Node                             Hyperplasia                                                                                  
Lymph Node, Mandibular                 Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia                                                                                  
Lymph Node, Mesenteric                 Ectasia                                                                                      
                                       Hematopoietic Cell Proliferation                                                             
                                       Hemorrhage                                                                                   
Mesentery: Fat                         Necrosis                                                                                     
Penis                                  Inflammation Chronic                                                                         
Preputial Gland                        Inflammation Chronic                                                                         
Salivary Glands                        Hyperplasia Lymphoid                                                                         
                                       Infiltration Cellular Lymphoid                                                               
Seminal Vesicle                        Dilatation                                                                                   
Skin                                   Edema                                                                                        
Spleen: Lymphoid Follicle              Hyperplasia                                                                                  
Stomach, Glandular: Glands             Hyperplasia Cystic                                                                           
Thymus                                 Hyperplasia Lymphoid                                                                         
Urethra                                Angiectasis                                                                                  
                                       Inflammation Chronic                                                                         
Urinary Bladder                        Edema                                                                                        
                                       Hemorrhage                                                                                   
                                       Inflammation Chronic                                                                         
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Bone                                   Fibrous Osteodystrophy                                                                       
Bone Marrow                            Hyperplasia                                                                                  
Clitoral Gland                         Cyst                                                                                         
Heart                                  Inflammation Chronic                                                                         
Intestine Large, Cecum                 Edema                                                                                        
Intestine Small, Duodenum: Epithelium  Hyperplasia                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                      AZT TRANSPLACENTAL CARCINOGENESIS STUDY                       DATE: 09/09/04       
EXPERIMENT: 99022 TEST: 02                                                                                     TIME: 14:02:01       
TEST TYPE:  PERINATAL EXPOS                     CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-15328                              ROUTE: IN-UTERO                                                NTP C#: C99022       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 30516-87-1      
Islets, Pancreatic                     Hyperplasia                                                                                  
Kidney                                 Cyst                                                                                         
                                       Infiltration Cellular Mixed Cell                                                             
                                       Inflammation Chronic                                                                         
                                       Nephropathy                                                                                  
Liver: Hepatocyte                      Hypertrophy                                                                                  
Lung                                   Foreign Body                                                                                 
                                       Infiltration Cellular Histiocyte                                                             
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
Lymph Node                             Hyperplasia                                                                                  
Lymph Node, Mandibular                 Hyperplasia                                                                                  
                                       Infiltration Cellular Plasma Cell                                                            
Lymph Node: Inguinal                   Hyperplasia                                                                                  
Mesentery: Fat                         Necrosis                                                                                     
Nose                                   Foreign Body                                                                                 
                                       Inflammation Chronic                                                                         
Ovary                                  Angiectasis                                                                                  
Pancreas: Acinus                       Cytoplasmic Alteration                                                                       
Pituitary Gland: Pars Distalis         Angiectasis                                                                                  
Skin                                   Cyst Epithelial Inclusion                                                                    
                                       Edema                                                                                        
                                       Ulcer                                                                                        
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation                                                                                 
Stomach, Forestomach                   Erosion                                                                                      
Thyroid Gland                          Degeneration Cystic                                                                          
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                  
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/50 (16%)       9/50 (18%)       7/50 (14%)       6/37 (16%)       6/32 (19%)                       | 
|POLY-3 RATE (b)    |        8/35.78          9/33.66          7/31.13          6/24.16          6/20.28                          | 
|POLY-3 PERCENT (g) |        22.4%            26.7%            22.5%            24.8%            29.6%                            | 
|TERMINAL (d)       |        5/19 (26%)       5/21 (24%)       3/13 (23%)       1/7 (14%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        322              147              320              157              563                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.212          P=0.524          P=0.504          P=0.358          P=0.327                          | 
|POLY 3             |        P=0.351          P=0.442          P=0.612          P=0.536          P=0.391                          | 
|POLY 1.5           |        P=0.373          P=0.448          P=0.579N         P=0.557          P=0.404                          | 
|POLY 6             |        P=0.339          P=0.461          P=0.576          P=0.517          P=0.398                          | 
|LOGISTIC REGRESSION|        P=0.432          P=0.514          P=0.526N         P=0.592N         P=0.448                          | 
|COCH-ARM / FISHERS |        P=0.448          P=0.500          P=0.500N         P=0.601          P=0.485                          | 
|ORDER RESTRICTED   |        P=0.502          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/50 (20%)      8/49 (16%)       11/50 (22%)      7/38 (18%)       6/42 (14%)                       | 
|POLY-3 RATE (b)    |        10/37.67         8/34.35          11/38.86         7/30.93          6/30.78                          | 
|POLY-3 PERCENT (g) |        26.6%            23.3%            28.3%            22.6%            19.5%                            | 
|TERMINAL (d)       |        4/20 (20%)       1/17 (6%)        5/24 (21%)       5/18 (28%)       3/19 (16%)                       | 
|FIRST INCIDENCE    |        287              219              460              359              43                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.210N         P=0.534N         P=0.569N         P=0.394N         P=0.322N                         | 
|POLY 3             |        P=0.269N         P=0.481N         P=0.533          P=0.463N         P=0.344N                         | 
|POLY 1.5           |        P=0.276N         P=0.442N         P=0.518          P=0.468N         P=0.334N                         | 
|POLY 6             |        P=0.273N         P=0.528N         P=0.563          P=0.479N         P=0.357N                         | 
|LOGISTIC REGRESSION|        P=0.301N         P=0.401N         P=0.519          P=0.493N         P=0.328N                         | 
|COCH-ARM / FISHERS |        P=0.303N         P=0.416N         P=0.500          P=0.538N         P=0.331N                         | 
|ORDER RESTRICTED   |        P=0.435N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia Diffuse                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          0/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia Diffuse                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/49 (4%)        0/50 (0%)        0/38 (0%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          2/31.07          0/36.65          0/29.97          1/29.68                          | 
|POLY-3 PERCENT (g) |        0.0%             6.4%             0.0%             0.0%             3.4%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/17 (0%)        0/24 (0%)        0/18 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              500              ---              ---              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.535          P=0.205          (e)              (e)              P=0.466                          | 
|POLY 3             |        P=0.544          P=0.210          (e)              (e)              P=0.467                          | 
|POLY 1.5           |        P=0.545          P=0.221          (e)              (e)              P=0.466                          | 
|POLY 6             |        P=0.539          P=0.201          (e)              (e)              P=0.469                          | 
|LOGISTIC REGRESSION|        P=0.523          P=0.238          (e)              (e)              P=0.508                          | 
|COCH-ARM / FISHERS |        P=0.527          P=0.242          (e)              (e)              P=0.457                          | 
|ORDER RESTRICTED   |        P=0.273          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        5/50 (10%)       3/50 (6%)        2/37 (5%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        2/33.95          5/31.08          3/29.72          2/21.52          0/19.14                          | 
|POLY-3 PERCENT (g) |        5.9%             16.1%            10.1%            9.3%             0.0%                             | 
|TERMINAL (d)       |        1/19 (5%)        3/21 (14%)       1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        373              523              536              580              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.275N         P=0.229          P=0.388          P=0.470          P=0.405N                         | 
|POLY 3             |        P=0.207N         P=0.176          P=0.439          P=0.522          P=0.372N                         | 
|POLY 1.5           |        P=0.194N         P=0.181          P=0.462          P=0.541          P=0.366N                         | 
|POLY 6             |        P=0.225N         P=0.184          P=0.412          P=0.501          P=0.380N                         | 
|LOGISTIC REGRESSION|        P=0.185N         P=0.188          P=0.471          P=0.567          P=0.334N                         | 
|COCH-ARM / FISHERS |        P=0.158N         P=0.218          P=0.500          P=0.571          P=0.369N                         | 
|ORDER RESTRICTED   |        P=0.185N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/49 (0%)        0/50 (0%)        0/38 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/30.04          0/36.65          0/29.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/17 (0%)        0/24 (0%)        0/18 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       5/50 (10%)       4/50 (8%)        4/37 (11%)       4/32 (13%)                       | 
|POLY-3 RATE (b)    |        6/33.13          5/30.37          4/30.01          4/21.27          4/19.52                          | 
|POLY-3 PERCENT (g) |        18.1%            16.5%            13.3%            18.8%            20.5%                            | 
|TERMINAL (d)       |        6/19 (32%)       5/21 (24%)       2/13 (15%)       2/7 (29%)        3/8 (38%)                        | 
|FIRST INCIDENCE    |        668 (T)          668 (T)          490              625              569                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.155          P=0.424N         P=0.587N         P=0.294          P=0.357                          | 
|POLY 3             |        P=0.423          P=0.563N         P=0.430N         P=0.615          P=0.560                          | 
|POLY 1.5           |        P=0.436          P=0.556N         P=0.408N         P=0.630N         P=0.563                          | 
|POLY 6             |        P=0.404          P=0.552N         P=0.458N         P=0.581          P=0.559                          | 
|LOGISTIC REGRESSION|        P=0.332          P=0.424N         P=0.512N         P=0.414          P=0.500                          | 
|COCH-ARM / FISHERS |        P=0.477          P=0.500N         P=0.370N         P=0.571N         P=0.602                          | 
|ORDER RESTRICTED   |        P=0.599          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/49 (0%)        0/50 (0%)        0/38 (0%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/30.04          0/36.65          0/29.97          1/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             3.5%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/17 (0%)        0/24 (0%)        0/18 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.125          (e)              (e)              (e)              P=0.490                          | 
|POLY 3             |        P=0.136          (e)              (e)              (e)              P=0.461                          | 
|POLY 1.5           |        P=0.130          (e)              (e)              (e)              P=0.462                          | 
|POLY 6             |        P=0.141          (e)              (e)              (e)              P=0.461                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.490                          | 
|COCH-ARM / FISHERS |        P=0.111          (e)              (e)              (e)              P=0.457                          | 
|ORDER RESTRICTED   |        P=0.062          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Capsule                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        2/50 (4%)        1/50 (2%)        3/37 (8%)        2/32 (6%)                        | 
|POLY-3 RATE (b)    |        2/33.13          2/30.37          1/29.15          3/21.18          2/20.07                          | 
|POLY-3 PERCENT (g) |        6.0%             6.6%             3.4%             14.2%            10.0%                            | 
|TERMINAL (d)       |        2/19 (11%)       2/21 (10%)       1/13 (8%)        2/7 (29%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          668 (T)          668 (T)          608              404                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.094          P=0.662N         P=0.634N         P=0.136          P=0.430                          | 
|POLY 3             |        P=0.219          P=0.664          P=0.545N         P=0.301          P=0.504                          | 
|POLY 1.5           |        P=0.217          P=0.667          P=0.527N         P=0.322          P=0.502                          | 
|POLY 6             |        P=0.219          P=0.672          P=0.569N         P=0.275          P=0.506                          | 
|LOGISTIC REGRESSION|        P=0.182          P=0.662N         P=0.634N         P=0.201          P=0.496                          | 
|COCH-ARM / FISHERS |        P=0.230          P=0.691N         P=0.500N         P=0.359          P=0.510                          | 
|ORDER RESTRICTED   |        P=0.343          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Capsule                                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/49 (2%)        0/50 (0%)        2/38 (5%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        1/34.96          1/30.57          0/36.65          2/29.97          2/29.11                          | 
|POLY-3 PERCENT (g) |        2.9%             3.3%             0.0%             6.7%             6.9%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/17 (0%)        0/24 (0%)        2/18 (11%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        668 (T)          521              ---              668 (T)          593                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.176          P=0.726          P=0.464N         P=0.463          P=0.462                          | 
|POLY 3             |        P=0.153          P=0.731          P=0.491N         P=0.446          P=0.436                          | 
|POLY 1.5           |        P=0.149          P=0.744          P=0.494N         P=0.437          P=0.435                          | 
|POLY 6             |        P=0.156          P=0.718          P=0.483N         P=0.450          P=0.438                          | 
|LOGISTIC REGRESSION|        P=0.154          P=0.743          (e)              P=0.463          P=0.432                          | 
|COCH-ARM / FISHERS |        P=0.142          P=0.747          P=0.500N         P=0.397          P=0.434                          | 
|ORDER RESTRICTED   |        P=0.263          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        1/49 (2%)        0/37 (0%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        2/33.72          0/30.37          1/28.71          0/20.93          1/19.75                          | 
|POLY-3 PERCENT (g) |        5.9%             0.0%             3.5%             0.0%             5.1%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        567              ---              668 (T)          ---              488                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.563N         P=0.253N         P=0.598N         P=0.363N         P=0.670N                         | 
|POLY 3             |        P=0.527N         P=0.260N         P=0.556N         P=0.350N         P=0.682N                         | 
|POLY 1.5           |        P=0.512N         P=0.256N         P=0.537N         P=0.333N         P=0.678N                         | 
|POLY 6             |        P=0.554N         P=0.259N         P=0.583N         P=0.373N         P=0.688N                         | 
|LOGISTIC REGRESSION|        P=0.524N         P=0.251N         P=0.554N         P=0.331N         P=0.666N                         | 
|COCH-ARM / FISHERS |        P=0.505N         P=0.247N         P=0.508N         P=0.327N         P=0.779                          | 
|ORDER RESTRICTED   |        P=0.391N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        3/49 (6%)        1/50 (2%)        0/38 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        1/34.96          3/30.04          1/36.65          0/29.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        2.9%             10.0%            2.7%             0.0%             0.0%                             | 
|TERMINAL (d)       |        1/20 (5%)        3/17 (18%)       1/24 (4%)        0/18 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        668 (T)          668 (T)          668 (T)          ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.072N         P=0.244          P=0.722N         P=0.521N         P=0.510N                         | 
|POLY 3             |        P=0.098N         P=0.251          P=0.751N         P=0.531N         P=0.539N                         | 
|POLY 1.5           |        P=0.097N         P=0.273          P=0.755N         P=0.536N         P=0.538N                         | 
|POLY 6             |        P=0.101N         P=0.227          P=0.743N         P=0.528N         P=0.539N                         | 
|LOGISTIC REGRESSION|        P=0.072N         P=0.244          P=0.722N         (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.098N         P=0.301          P=0.753N         P=0.568N         P=0.543N                         | 
|ORDER RESTRICTED   |        P=0.131N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Fibrous Osteodystrophy                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        1/50 (2%)        1/37 (3%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          1/29.53          1/21.43          1/19.32                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             3.4%             4.7%             5.2%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              570              531              627                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.106          (e)              P=0.469          P=0.428          P=0.415                          | 
|POLY 3             |        P=0.100          (e)              P=0.477          P=0.414          P=0.393                          | 
|POLY 1.5           |        P=0.101          (e)              P=0.486          P=0.422          P=0.395                          | 
|POLY 6             |        P=0.098          (e)              P=0.466          P=0.403          P=0.391                          | 
|LOGISTIC REGRESSION|        P=0.102          (e)              P=0.490          P=0.440          P=0.388                          | 
|COCH-ARM / FISHERS |        P=0.109          (e)              P=0.500          P=0.425          P=0.390                          | 
|ORDER RESTRICTED   |        P=0.219          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Fibrous Osteodystrophy                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        7/50 (14%)       9/50 (18%)       6/40 (15%)       4/42 (10%)                       | 
|POLY-3 RATE (b)    |        2/35.72          7/35.55          9/41.01          6/34.10          4/31.68                          | 
|POLY-3 PERCENT (g) |        5.6%             19.7%            22.0%            17.6%            12.6%                            | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        443              326              328              359              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.417          P=0.070          P=0.048 *        P=0.134          P=0.267                          | 
|POLY 3             |        P=0.434          P=0.073          P=0.041 *        P=0.113          P=0.280                          | 
|POLY 1.5           |        P=0.401          P=0.077          P=0.034 *        P=0.100          P=0.271                          | 
|POLY 6             |        P=0.465          P=0.071          P=0.054          P=0.125          P=0.291                          | 
|LOGISTIC REGRESSION|        P=0.314          P=0.088          P=0.024 *        P=0.049 *        P=0.281                          | 
|COCH-ARM / FISHERS |        P=0.346          P=0.080          P=0.026 *        P=0.074          P=0.259                          | 
|ORDER RESTRICTED   |        P=0.132          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        43/50 (86%)      29/50 (58%)      35/50 (70%)      27/37 (73%)      24/32 (75%)                      | 
|POLY-3 RATE (b)    |        43/48.79         29/41.81         35/43.29         27/33.80         24/27.74                         | 
|POLY-3 PERCENT (g) |        88.1%            69.4%            80.9%            79.9%            86.5%                            | 
|TERMINAL (d)       |        15/19 (79%)      11/21 (52%)      10/13 (77%)      3/7 (43%)        5/8 (63%)                        | 
|FIRST INCIDENCE    |        104              147              147              157              192                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.149          P=0.050N         P=0.530          P=0.313          P=0.466                          | 
|POLY 3             |        P=0.460          P=0.020N*        P=0.231N         P=0.228N         P=0.562N                         | 
|POLY 1.5           |        P=0.471          P=0.009N**       P=0.130N         P=0.172N         P=0.501N                         | 
|POLY 6             |        P=0.452          P=0.037N*        P=0.422N         P=0.301N         P=0.593N                         | 
|LOGISTIC REGRESSION|        P=0.459N         P=0.002N**       P=0.041N*        P=0.068N         P=0.193N                         | 
|COCH-ARM / FISHERS |        P=0.455N         P=0.002N**       P=0.045N*        P=0.108N         P=0.167N                         | 
|ORDER RESTRICTED   |        P=0.262N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        33/50 (66%)      24/50 (48%)      30/50 (60%)      22/40 (55%)      26/42 (62%)                      | 
|POLY-3 RATE (b)    |        33/47.13         24/40.22         30/43.46         22/36.73         26/38.16                         | 
|POLY-3 PERCENT (g) |        70.0%            59.7%            69.0%            59.9%            68.1%                            | 
|TERMINAL (d)       |        11/20 (55%)      6/18 (33%)       13/24 (54%)      8/20 (40%)       10/19 (53%)                      | 
|FIRST INCIDENCE    |        105              207              182              414              43                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.314N         P=0.283N         P=0.220N         P=0.105N         P=0.404N                         | 
|POLY 3             |        P=0.451N         P=0.208N         P=0.551N         P=0.225N         P=0.520N                         | 
|POLY 1.5           |        P=0.482N         P=0.134N         P=0.501N         P=0.211N         P=0.495N                         | 
|POLY 6             |        P=0.424N         P=0.271N         P=0.551N         P=0.232N         P=0.523N                         | 
|LOGISTIC REGRESSION|        P=0.489          P=0.043N*        P=0.345N         P=0.303N         P=0.404N                         | 
|COCH-ARM / FISHERS |        P=0.501          P=0.053N         P=0.339N         P=0.199N         P=0.424N                         | 
|ORDER RESTRICTED   |        P=0.478N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        0/50 (0%)        0/37 (0%)        2/32 (6%)                        | 
|POLY-3 RATE (b)    |        0/33.13          1/30.76          0/29.15          0/20.93          2/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             3.3%             0.0%             0.0%             10.5%                            | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         2/8 (25%)                        | 
|FIRST INCIDENCE    |        ---              567              ---              ---              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.033 *        P=0.493          (e)              (e)              P=0.076                          | 
|POLY 3             |        P=0.054          P=0.485          (e)              (e)              P=0.126                          | 
|POLY 1.5           |        P=0.057          P=0.486          (e)              (e)              P=0.129                          | 
|POLY 6             |        P=0.050          P=0.491          (e)              (e)              P=0.122                          | 
|LOGISTIC REGRESSION|        P=0.054          P=0.492          (e)              (e)              P=0.076                          | 
|COCH-ARM / FISHERS |        P=0.064          P=0.500          (e)              (e)              P=0.149                          | 
|ORDER RESTRICTED   |        P=0.015 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          0/36.65          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        22/50 (44%)      18/50 (36%)      25/50 (50%)      14/40 (35%)      12/42 (29%)                      | 
|POLY-3 RATE (b)    |        22/39.10         18/34.48         25/42.10         14/34.07         12/29.74                         | 
|POLY-3 PERCENT (g) |        56.3%            52.2%            59.4%            41.1%            40.4%                            | 
|TERMINAL (d)       |        10/20 (50%)      10/18 (56%)      12/24 (50%)      7/20 (35%)       10/19 (53%)                      | 
|FIRST INCIDENCE    |        443              412              332              497              479                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.025N*        P=0.521N         P=0.557N         P=0.116N         P=0.078N                         | 
|POLY 3             |        P=0.044N*        P=0.452N         P=0.476          P=0.136N         P=0.134N                         | 
|POLY 1.5           |        P=0.047N*        P=0.347N         P=0.424          P=0.152N         P=0.111N                         | 
|POLY 6             |        P=0.053N         P=0.586N         P=0.543          P=0.138N         P=0.187N                         | 
|LOGISTIC REGRESSION|        P=0.033N*        P=0.425N         P=0.382          P=0.134N         P=0.093N                         | 
|COCH-ARM / FISHERS |        P=0.068N         P=0.270N         P=0.344          P=0.258N         P=0.095N                         | 
|ORDER RESTRICTED   |        P=0.154N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        23/50 (46%)      19/50 (38%)      17/50 (34%)      14/40 (35%)      16/42 (38%)                      | 
|POLY-3 RATE (b)    |        23/39.22         19/34.35         17/39.14         14/33.17         16/32.10                         | 
|POLY-3 PERCENT (g) |        58.7%            55.3%            43.4%            42.2%            49.8%                            | 
|TERMINAL (d)       |        11/20 (55%)      11/18 (61%)      9/24 (38%)       8/20 (40%)       10/19 (53%)                      | 
|FIRST INCIDENCE    |        443              500              332              539              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.120N         P=0.550N         P=0.084N         P=0.081N         P=0.256N                         | 
|POLY 3             |        P=0.167N         P=0.478N         P=0.123N         P=0.113N         P=0.300N                         | 
|POLY 1.5           |        P=0.197N         P=0.362N         P=0.126N         P=0.119N         P=0.295N                         | 
|POLY 6             |        P=0.165N         P=0.593          P=0.121N         P=0.129N         P=0.328N                         | 
|LOGISTIC REGRESSION|        P=0.173N         P=0.453N         P=0.113N         P=0.081N         P=0.305N                         | 
|COCH-ARM / FISHERS |        P=0.270N         P=0.272N         P=0.154N         P=0.201N         P=0.291N                         | 
|ORDER RESTRICTED   |        P=0.198N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Atypia Cellular                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        3/50 (6%)        3/50 (6%)        3/37 (8%)        3/32 (9%)                        | 
|POLY-3 RATE (b)    |        1/33.13          3/31.36          3/30.69          3/21.41          3/19.67                          | 
|POLY-3 PERCENT (g) |        3.0%             9.6%             9.8%             14.0%            15.3%                            | 
|TERMINAL (d)       |        1/19 (5%)        2/21 (10%)       0/13 (0%)        1/7 (14%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        668 (T)          157              147              607              563                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.051          P=0.332          P=0.246          P=0.090          P=0.102                          | 
|POLY 3             |        P=0.079          P=0.283          P=0.276          P=0.163          P=0.139                          | 
|POLY 1.5           |        P=0.083          P=0.285          P=0.288          P=0.176          P=0.141                          | 
|POLY 6             |        P=0.075          P=0.290          P=0.261          P=0.149          P=0.138                          | 
|LOGISTIC REGRESSION|        P=0.094          P=0.301          P=0.318          P=0.132          P=0.129                          | 
|COCH-ARM / FISHERS |        P=0.104          P=0.309          P=0.309          P=0.204          P=0.162                          | 
|ORDER RESTRICTED   |        P=0.141          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Atypia Cellular                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Spermatocele                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)        0/37 (0%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          2/29.77          0/20.93          1/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             6.7%             0.0%             5.2%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        ---              ---              544              ---              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.204          (e)              P=0.193          (e)              P=0.328                          | 
|POLY 3             |        P=0.224          (e)              P=0.213          (e)              P=0.391                          | 
|POLY 1.5           |        P=0.233          (e)              P=0.221          (e)              P=0.394                          | 
|POLY 6             |        P=0.210          (e)              P=0.202          (e)              P=0.387                          | 
|LOGISTIC REGRESSION|        P=0.235          (e)              P=0.219          (e)              P=0.328                          | 
|COCH-ARM / FISHERS |        P=0.256          (e)              P=0.247          (e)              P=0.390                          | 
|ORDER RESTRICTED   |        P=0.216          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Spermatocele                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        1/49 (2%)        1/37 (3%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        2/33.40          0/30.37          1/28.48          1/21.68          1/19.32                          | 
|POLY-3 PERCENT (g) |        6.0%             0.0%             3.5%             4.6%             5.2%                             | 
|TERMINAL (d)       |        1/19 (5%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        601              ---              651              419              627                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.428          P=0.250N         P=0.617N         P=0.715N         P=0.712N                         | 
|POLY 3             |        P=0.507          P=0.258N         P=0.556N         P=0.648N         P=0.686N                         | 
|POLY 1.5           |        P=0.510          P=0.255N         P=0.537N         P=0.633N         P=0.680N                         | 
|POLY 6             |        P=0.498          P=0.255N         P=0.580N         P=0.668N         P=0.692N                         | 
|LOGISTIC REGRESSION|        P=0.492          P=0.253N         P=0.581N         P=0.624N         P=0.693N                         | 
|COCH-ARM / FISHERS |        P=0.517          P=0.247N         P=0.508N         P=0.613N         P=0.779                          | 
|ORDER RESTRICTED   |        P=0.530N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        0/49 (0%)        1/50 (2%)        2/40 (5%)        1/41 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.94          0/30.96          1/36.65          2/31.97          1/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.7%             6.3%             3.5%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        1/24 (4%)        2/20 (10%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        ---              ---              668 (T)          668 (T)          668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.129          (e)              P=0.536          P=0.237          P=0.490                          | 
|POLY 3             |        P=0.111          (e)              P=0.510          P=0.216          P=0.461                          | 
|POLY 1.5           |        P=0.107          (e)              P=0.506          P=0.210          P=0.462                          | 
|POLY 6             |        P=0.116          (e)              P=0.517          P=0.220          P=0.461                          | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.536          P=0.237          P=0.490                          | 
|COCH-ARM / FISHERS |        P=0.102          (e)              P=0.505          P=0.199          P=0.456                          | 
|ORDER RESTRICTED   |        P=0.177          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/50 (24%)      7/50 (14%)       19/50 (38%)      13/37 (35%)      7/32 (22%)                       | 
|POLY-3 RATE (b)    |        12/35.85         7/30.49          19/35.38         13/25.36         7/20.85                          | 
|POLY-3 PERCENT (g) |        33.5%            23.0%            53.7%            51.3%            33.6%                            | 
|TERMINAL (d)       |        6/19 (32%)       6/21 (29%)       3/13 (23%)       3/7 (43%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        322              640              147              298              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.077          P=0.134N         P=0.032 *        P=0.029 *        P=0.469                          | 
|POLY 3             |        P=0.205          P=0.248N         P=0.060          P=0.120          P=0.612                          | 
|POLY 1.5           |        P=0.213          P=0.222N         P=0.068          P=0.136          P=0.602N                         | 
|POLY 6             |        P=0.193          P=0.262N         P=0.063          P=0.104          P=0.606                          | 
|LOGISTIC REGRESSION|        P=0.198          P=0.195N         P=0.065          P=0.128          P=0.592N                         | 
|COCH-ARM / FISHERS |        P=0.267          P=0.154N         P=0.097          P=0.185          P=0.523N                         | 
|ORDER RESTRICTED   |        P=0.138          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        2/49 (4%)        6/50 (12%)       1/40 (3%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        3/36.19          2/31.43          6/37.61          1/31.97          2/29.97                          | 
|POLY-3 PERCENT (g) |        8.3%             6.4%             16.0%            3.1%             6.7%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        2/24 (8%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        255              560              514              668 (T)          453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.292N         P=0.571N         P=0.316          P=0.328N         P=0.577N                         | 
|POLY 3             |        P=0.296N         P=0.565N         P=0.257          P=0.349N         P=0.586N                         | 
|POLY 1.5           |        P=0.317N         P=0.538N         P=0.249          P=0.357N         P=0.588N                         | 
|POLY 6             |        P=0.278N         P=0.592N         P=0.278          P=0.345N         P=0.583N                         | 
|LOGISTIC REGRESSION|        P=0.342N         P=0.507N         P=0.247          P=0.433N         P=0.567N                         | 
|COCH-ARM / FISHERS |        P=0.348N         P=0.510N         P=0.243          P=0.397N         P=0.583N                         | 
|ORDER RESTRICTED   |        P=0.362N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        5/50 (10%)       3/50 (6%)        2/37 (5%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        1/33.13          5/31.97          3/29.40          2/21.67          1/19.75                          | 
|POLY-3 PERCENT (g) |        3.0%             15.6%            10.2%            9.2%             5.1%                             | 
|TERMINAL (d)       |        1/19 (5%)        2/21 (10%)       2/13 (15%)       0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          157              608              501              488                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.518          P=0.110          P=0.185          P=0.275          P=0.608                          | 
|POLY 3             |        P=0.507N         P=0.089          P=0.261          P=0.354          P=0.641                          | 
|POLY 1.5           |        P=0.497N         P=0.089          P=0.278          P=0.367          P=0.641                          | 
|POLY 6             |        P=0.520N         P=0.096          P=0.240          P=0.339          P=0.642                          | 
|LOGISTIC REGRESSION|        P=0.479N         P=0.096          P=0.210          P=0.351          P=0.647                          | 
|COCH-ARM / FISHERS |        P=0.450N         P=0.102          P=0.309          P=0.387          P=0.631                          | 
|ORDER RESTRICTED   |        P=0.325          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       1/49 (2%)        2/50 (4%)        2/40 (5%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        7/37.15          1/31.02          2/36.65          2/32.23          2/29.43                          | 
|POLY-3 PERCENT (g) |        18.8%            3.2%             5.5%             6.2%             6.8%                             | 
|TERMINAL (d)       |        3/20 (15%)       0/18 (0%)        2/24 (8%)        1/20 (5%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        255              655              668 (T)          603              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.113N         P=0.061N         P=0.063N         P=0.104N         P=0.133N                         | 
|POLY 3             |        P=0.113N         P=0.051N         P=0.078N         P=0.111N         P=0.141N                         | 
|POLY 1.5           |        P=0.127N         P=0.041N*        P=0.078N         P=0.117N         P=0.138N                         | 
|POLY 6             |        P=0.102N         P=0.066N         P=0.075N         P=0.109N         P=0.147N                         | 
|LOGISTIC REGRESSION|        P=0.139N         P=0.036N*        P=0.078N         P=0.146N         P=0.129N                         | 
|COCH-ARM / FISHERS |        P=0.149N         P=0.032N*        P=0.080N         P=0.144N         P=0.128N                         | 
|ORDER RESTRICTED   |        P=0.035N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        1/50 (2%)        1/37 (3%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          2/31.49          1/29.88          1/21.92          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             6.4%             3.4%             4.6%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              432              434              157              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.524N         P=0.224          P=0.490          P=0.448          (e)                              | 
|POLY 3             |        P=0.548N         P=0.225          P=0.479          P=0.418          (e)                              | 
|POLY 1.5           |        P=0.540N         P=0.223          P=0.487          P=0.426          (e)                              | 
|POLY 6             |        P=0.561N         P=0.233          P=0.469          P=0.406          (e)                              | 
|LOGISTIC REGRESSION|        P=0.458N         P=0.246          P=0.521          P=0.441          (e)                              | 
|COCH-ARM / FISHERS |        P=0.505N         P=0.247          P=0.500          P=0.425          (e)                              | 
|ORDER RESTRICTED   |        P=0.403          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        3/49 (6%)        2/50 (4%)        1/40 (3%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        2/35.82          3/32.81          2/38.05          1/32.44          2/30.54                          | 
|POLY-3 PERCENT (g) |        5.6%             9.1%             5.3%             3.1%             6.6%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        352              417              322              541              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.459N         P=0.463          P=0.674N         P=0.531N         P=0.641                          | 
|POLY 3             |        P=0.452N         P=0.460          P=0.673N         P=0.535N         P=0.637                          | 
|POLY 1.5           |        P=0.461N         P=0.476          P=0.682N         P=0.545N         P=0.634                          | 
|POLY 6             |        P=0.446N         P=0.445          P=0.658N         P=0.526N         P=0.641                          | 
|LOGISTIC REGRESSION|        P=0.487N         P=0.498          P=0.677          P=0.664N         P=0.674                          | 
|COCH-ARM / FISHERS |        P=0.483N         P=0.490          P=0.691N         P=0.584N         P=0.623                          | 
|ORDER RESTRICTED   |        P=0.577N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        4/50 (8%)        5/50 (10%)       3/37 (8%)        3/32 (9%)                        | 
|POLY-3 RATE (b)    |        2/34.18          4/32.17          5/30.52          3/21.52          3/19.44                          | 
|POLY-3 PERCENT (g) |        5.9%             12.4%            16.4%            13.9%            15.4%                            | 
|TERMINAL (d)       |        0/19 (0%)        2/21 (10%)       0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        104              236              544              563              635                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.165          P=0.340          P=0.140          P=0.230          P=0.232                          | 
|POLY 3             |        P=0.192          P=0.306          P=0.167          P=0.295          P=0.254                          | 
|POLY 1.5           |        P=0.209          P=0.306          P=0.181          P=0.315          P=0.261                          | 
|POLY 6             |        P=0.174          P=0.316          P=0.155          P=0.273          P=0.248                          | 
|LOGISTIC REGRESSION|        P=0.249          P=0.393          P=0.215          P=0.371          P=0.299                          | 
|COCH-ARM / FISHERS |        P=0.268          P=0.339          P=0.218          P=0.359          P=0.296                          | 
|ORDER RESTRICTED   |        P=0.296          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/49 (0%)        3/50 (6%)        0/40 (0%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/30.96          3/39.34          0/31.97          1/29.09                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             7.6%             0.0%             3.4%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              181              ---              598                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.388          (e)              P=0.128          (e)              P=0.445                          | 
|POLY 3             |        P=0.449          (e)              P=0.140          (e)              P=0.463                          | 
|POLY 1.5           |        P=0.424          (e)              P=0.133          (e)              P=0.463                          | 
|POLY 6             |        P=0.475          (e)              P=0.150          (e)              P=0.465                          | 
|LOGISTIC REGRESSION|        P=0.424          (e)              P=0.063          (e)              P=0.462                          | 
|COCH-ARM / FISHERS |        P=0.380          (e)              P=0.121          (e)              P=0.457                          | 
|ORDER RESTRICTED   |        P=0.265          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum                                                                                                           | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        13/49 (27%)      11/49 (22%)      8/48 (17%)       14/35 (40%)      2/30 (7%)                        | 
|POLY-3 RATE (b)    |        13/35.52         11/32.02         8/31.58          14/24.03         2/19.56                          | 
|POLY-3 PERCENT (g) |        36.6%            34.4%            25.3%            58.3%            10.2%                            | 
|TERMINAL (d)       |        8/19 (42%)       8/21 (38%)       2/13 (15%)       4/7 (57%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        392              385              147              341              495                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.503N         P=0.372N         P=0.372N         P=0.019 *        P=0.073N                         | 
|POLY 3             |        P=0.254N         P=0.525N         P=0.228N         P=0.073          P=0.033N*                        | 
|POLY 1.5           |        P=0.234N         P=0.503N         P=0.200N         P=0.092          P=0.032N*                        | 
|POLY 6             |        P=0.298N         P=0.528N         P=0.266N         P=0.060          P=0.037N*                        | 
|LOGISTIC REGRESSION|        P=0.246N         P=0.490N         P=0.209N         P=0.073          P=0.033N*                        | 
|COCH-ARM / FISHERS |        P=0.213N         P=0.407N         P=0.176N         P=0.143          P=0.025N*                        | 
|ORDER RESTRICTED   |        P=0.039N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Cecum                                                                                                           | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/47 (6%)        3/48 (6%)        4/45 (9%)        4/38 (11%)       8/40 (20%)                       | 
|POLY-3 RATE (b)    |        3/34.13          3/31.75          4/36.01          4/32.38          8/31.32                          | 
|POLY-3 PERCENT (g) |        8.8%             9.5%             11.1%            12.4%            25.5%                            | 
|TERMINAL (d)       |        1/20 (5%)        1/18 (6%)        1/24 (4%)        1/20 (5%)        2/19 (11%)                       | 
|FIRST INCIDENCE    |        588              500              362              530              467                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.027 *        P=0.546          P=0.539          P=0.457          P=0.065                          | 
|POLY 3             |        P=0.026 *        P=0.631          P=0.530          P=0.471          P=0.066                          | 
|POLY 1.5           |        P=0.021 *        P=0.653          P=0.509          P=0.448          P=0.060                          | 
|POLY 6             |        P=0.031 *        P=0.603          P=0.556          P=0.490          P=0.074                          | 
|LOGISTIC REGRESSION|        P=0.014 *        P=0.648          P=0.470          P=0.410          P=0.057                          | 
|COCH-ARM / FISHERS |        P=0.015 *        P=0.651N         P=0.475          P=0.381          P=0.057                          | 
|ORDER RESTRICTED   |        P=0.031 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/48 (0%)        0/50 (0%)        2/49 (4%)        1/37 (3%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/31.88          0/30.37          2/28.73          1/21.28          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             7.0%             4.7%             0.0%                             | 
|TERMINAL (d)       |        0/18 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              605              580              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.445          (e)              P=0.194          P=0.423          (e)                              | 
|POLY 3             |        P=0.439          (e)              P=0.213          P=0.420          (e)                              | 
|POLY 1.5           |        P=0.445          (e)              P=0.224          P=0.429          (e)                              | 
|POLY 6             |        P=0.430          (e)              P=0.202          P=0.409          (e)                              | 
|LOGISTIC REGRESSION|        P=0.454          (e)              P=0.212          P=0.430          (e)                              | 
|COCH-ARM / FISHERS |        P=0.475          (e)              P=0.253          P=0.435          (e)                              | 
|ORDER RESTRICTED   |        P=0.302          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large, Colon                                                                                                           | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/49 (2%)        1/49 (2%)        0/39 (0%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          1/31.54          1/37.21          0/31.44          1/29.45                          | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             2.7%             0.0%             3.4%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              500              460              ---              474                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.438          P=0.478          P=0.505          (e)              P=0.467                          | 
|POLY 3             |        P=0.464          P=0.479          P=0.512          (e)              P=0.466                          | 
|POLY 1.5           |        P=0.452          P=0.488          P=0.506          (e)              P=0.464                          | 
|POLY 6             |        P=0.474          P=0.470          P=0.522          (e)              P=0.468                          | 
|LOGISTIC REGRESSION|        P=0.421          P=0.499          P=0.478          (e)              P=0.475                          | 
|COCH-ARM / FISHERS |        P=0.421          P=0.495          P=0.495          (e)              P=0.457                          | 
|ORDER RESTRICTED   |        P=0.276          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum                                                                                                        | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/49 (0%)        0/36 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/32.39          0/30.37          0/28.72          0/19.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum                                                                                                        | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/50 (2%)        0/48 (0%)        0/40 (0%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        1/34.96          1/31.04          0/36.41          0/31.97          2/29.78                          | 
|POLY-3 PERCENT (g) |        2.9%             3.2%             0.0%             0.0%             6.7%                             | 
|TERMINAL (d)       |        1/20 (5%)        1/18 (6%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        668 (T)          668 (T)          ---              ---              530                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.323          P=0.740          P=0.464N         P=0.500N         P=0.437                          | 
|POLY 3             |        P=0.330          P=0.735          P=0.492N         P=0.518N         P=0.444                          | 
|POLY 1.5           |        P=0.322          P=0.748          P=0.498N         P=0.524N         P=0.439                          | 
|POLY 6             |        P=0.333          P=0.720          P=0.484N         P=0.513N         P=0.452                          | 
|LOGISTIC REGRESSION|        P=0.300          P=0.740          (e)              (e)              P=0.436                          | 
|COCH-ARM / FISHERS |        P=0.293          P=0.753N         P=0.510N         P=0.556N         P=0.434                          | 
|ORDER RESTRICTED   |        P=0.145          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum                                                                                                        | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/49 (0%)        0/36 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/32.39          0/30.37          0/28.72          0/19.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum                                                                                                        | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/48 (4%)        0/40 (0%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          2/36.97          0/31.97          1/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.4%             0.0%             3.5%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        ---              ---              537              ---              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.345          (e)              P=0.262          (e)              P=0.490                          | 
|POLY 3             |        P=0.379          (e)              P=0.249          (e)              P=0.461                          | 
|POLY 1.5           |        P=0.358          (e)              P=0.241          (e)              P=0.462                          | 
|POLY 6             |        P=0.400          (e)              P=0.261          (e)              P=0.461                          | 
|LOGISTIC REGRESSION|        P=0.330          (e)              P=0.233          (e)              P=0.490                          | 
|COCH-ARM / FISHERS |        P=0.319          (e)              P=0.237          (e)              P=0.457                          | 
|ORDER RESTRICTED   |        P=0.269          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum: Epithelium                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/49 (6%)        4/50 (8%)        4/49 (8%)        1/36 (3%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        3/32.98          4/31.97          4/28.72          1/20.16          1/19.44                          | 
|POLY-3 PERCENT (g) |        9.1%             12.5%            13.9%            5.0%             5.1%                             | 
|TERMINAL (d)       |        2/19 (11%)       1/21 (5%)        4/13 (31%)       0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        497              467              668 (T)          612              593                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.356N         P=0.497          P=0.317          P=0.611N         P=0.574N                         | 
|POLY 3             |        P=0.252N         P=0.483          P=0.423          P=0.493N         P=0.507N                         | 
|POLY 1.5           |        P=0.232N         P=0.479          P=0.454          P=0.466N         P=0.500N                         | 
|POLY 6             |        P=0.283N         P=0.502          P=0.381          P=0.527N         P=0.515N                         | 
|LOGISTIC REGRESSION|        P=0.232N         P=0.484          P=0.386          P=0.489N         P=0.501N                         | 
|COCH-ARM / FISHERS |        P=0.194N         P=0.511          P=0.500          P=0.432N         P=0.482N                         | 
|ORDER RESTRICTED   |        P=0.404N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Duodenum: Epithelium                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/50 (24%)      7/50 (14%)       12/48 (25%)      4/40 (10%)       9/42 (21%)                       | 
|POLY-3 RATE (b)    |        12/37.69         7/34.28          12/36.78         4/31.97          9/29.70                          | 
|POLY-3 PERCENT (g) |        31.8%            20.4%            32.6%            12.5%            30.3%                            | 
|TERMINAL (d)       |        7/20 (35%)       2/18 (11%)       8/24 (33%)       4/20 (20%)       7/19 (37%)                       | 
|FIRST INCIDENCE    |        372              341              631              668 (T)          530                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.220N         P=0.247N         P=0.430N         P=0.032N*        P=0.419N                         | 
|POLY 3             |        P=0.308N         P=0.200N         P=0.570          P=0.047N*        P=0.552N                         | 
|POLY 1.5           |        P=0.321N         P=0.172N         P=0.565          P=0.050N         P=0.529N                         | 
|POLY 6             |        P=0.306N         P=0.232N         P=0.584          P=0.048N*        P=0.576N                         | 
|LOGISTIC REGRESSION|        P=0.299N         P=0.164N         P=0.557N         P=0.047N*        P=0.501N                         | 
|COCH-ARM / FISHERS |        P=0.354N         P=0.154N         P=0.547          P=0.072N         P=0.484N                         | 
|ORDER RESTRICTED   |        P=0.270N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Jejunum: Epithelium                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/49 (8%)        2/50 (4%)        0/46 (0%)        1/36 (3%)        1/29 (3%)                        | 
|POLY-3 RATE (b)    |        4/33.56          2/31.21          0/28.05          1/20.92          1/18.70                          | 
|POLY-3 PERCENT (g) |        11.9%            6.4%             0.0%             4.8%             5.4%                             | 
|TERMINAL (d)       |        1/19 (5%)        1/21 (5%)        0/13 (0%)        1/7 (14%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        413              363              ---              668 (T)          488                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.281N         P=0.354N         P=0.106N         P=0.453N         P=0.391N                         | 
|POLY 3             |        P=0.221N         P=0.369N         P=0.083N         P=0.345N         P=0.389N                         | 
|POLY 1.5           |        P=0.213N         P=0.363N         P=0.076N         P=0.318N         P=0.385N                         | 
|POLY 6             |        P=0.237N         P=0.368N         P=0.095N         P=0.387N         P=0.397N                         | 
|LOGISTIC REGRESSION|        P=0.214N         P=0.341N         P=0.075N         P=0.317N         P=0.372N                         | 
|COCH-ARM / FISHERS |        P=0.208N         P=0.329N         P=0.067N         P=0.291N         P=0.381N                         | 
|ORDER RESTRICTED   |        P=0.191N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small, Jejunum: Epithelium                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/46 (0%)        1/49 (2%)        1/46 (2%)        0/40 (0%)        1/40 (3%)                        | 
|POLY-3 RATE (b)    |        0/32.73          1/31.06          1/35.55          0/31.97          1/29.37                          | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             2.8%             0.0%             3.4%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        1/24 (4%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              644              668 (T)          ---              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.449          P=0.464          P=0.536          (e)              P=0.466                          | 
|POLY 3             |        P=0.467          P=0.490          P=0.516          (e)              P=0.478                          | 
|POLY 1.5           |        P=0.457          P=0.500          P=0.510          (e)              P=0.476                          | 
|POLY 6             |        P=0.473          P=0.477          P=0.525          (e)              P=0.480                          | 
|LOGISTIC REGRESSION|        P=0.421          P=0.475          P=0.536          (e)              P=0.516                          | 
|COCH-ARM / FISHERS |        P=0.428          P=0.516          P=0.500          (e)              P=0.465                          | 
|ORDER RESTRICTED   |        P=0.287          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/50 (30%)      13/50 (26%)      12/50 (24%)      6/36 (17%)       6/31 (19%)                       | 
|POLY-3 RATE (b)    |        15/38.90         13/34.71         12/33.74         6/22.28          6/20.45                          | 
|POLY-3 PERCENT (g) |        38.6%            37.5%            35.6%            26.9%            29.3%                            | 
|TERMINAL (d)       |        4/19 (21%)       6/21 (29%)       1/13 (8%)        1/6 (17%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        322              236              320              341              473                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.263N         P=0.448N         P=0.567N         P=0.359N         P=0.348N                         | 
|POLY 3             |        P=0.177N         P=0.557N         P=0.492N         P=0.262N         P=0.338N                         | 
|POLY 1.5           |        P=0.141N         P=0.529N         P=0.429N         P=0.202N         P=0.305N                         | 
|POLY 6             |        P=0.237N         P=0.563N         P=0.558N         P=0.348N         P=0.381N                         | 
|LOGISTIC REGRESSION|        P=0.104N         P=0.438N         P=0.343N         P=0.132N         P=0.230N                         | 
|COCH-ARM / FISHERS |        P=0.089N         P=0.412N         P=0.326N         P=0.121N         P=0.213N                         | 
|ORDER RESTRICTED   |        P=0.399N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        5/49 (10%)       6/49 (12%)       7/40 (18%)       10/41 (24%)                      | 
|POLY-3 RATE (b)    |        2/35.26          5/31.54          6/38.30          7/32.22          10/31.73                         | 
|POLY-3 PERCENT (g) |        5.7%             15.9%            15.7%            21.7%            31.5%                            | 
|TERMINAL (d)       |        1/20 (5%)        4/18 (22%)       3/24 (13%)       6/20 (30%)       4/19 (21%)                       | 
|FIRST INCIDENCE    |        593              500              425              608              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.005 **       P=0.162          P=0.176          P=0.075          P=0.010 *                        | 
|POLY 3             |        P=0.003 **       P=0.168          P=0.158          P=0.053          P=0.005 **                       | 
|POLY 1.5           |        P=0.002 **       P=0.189          P=0.145          P=0.049 *        P=0.004 **                       | 
|POLY 6             |        P=0.004 **       P=0.146          P=0.177          P=0.055          P=0.007 **                       | 
|LOGISTIC REGRESSION|        P=0.002 **       P=0.153          P=0.133          P=0.063          P=0.005 **                       | 
|COCH-ARM / FISHERS |        P=0.002 **       P=0.210          P=0.128          P=0.038 *        P=0.005 **                       | 
|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Amyloid Deposition                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        3/35.36          0/30.37          0/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        8.5%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        373              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.057N         P=0.148N         P=0.134N         P=0.210N         P=0.240N                         | 
|POLY 3             |        P=0.044N*        P=0.146N         P=0.155N         P=0.231N         P=0.250N                         | 
|POLY 1.5           |        P=0.043N*        P=0.140N         P=0.140N         P=0.210N         P=0.239N                         | 
|POLY 6             |        P=0.048N*        P=0.148N         P=0.177N         P=0.258N         P=0.263N                         | 
|LOGISTIC REGRESSION|        P=0.043N*        P=0.087N         P=0.098N         P=0.140N         P=0.159N                         | 
|COCH-ARM / FISHERS |        P=0.050N         P=0.121N         P=0.121N         P=0.185N         P=0.221N                         | 
|ORDER RESTRICTED   |        P=0.042N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Amyloid Deposition                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        1/50 (2%)        0/40 (0%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        2/34.96          0/31.04          1/37.53          0/31.97          2/30.57                          | 
|POLY-3 PERCENT (g) |        5.7%             0.0%             2.7%             0.0%             6.5%                             | 
|TERMINAL (d)       |        2/20 (10%)       0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        668 (T)          ---              328              ---              43                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.459          P=0.260N         P=0.455N         P=0.237N         P=0.656                          | 
|POLY 3             |        P=0.491          P=0.263N         P=0.475N         P=0.255N         P=0.647                          | 
|POLY 1.5           |        P=0.469          P=0.250N         P=0.485N         P=0.263N         P=0.642                          | 
|POLY 6             |        P=0.509          P=0.279N         P=0.461N         P=0.250N         P=0.653                          | 
|LOGISTIC REGRESSION|        P=0.429          (e)              P=0.503N         (e)              P=0.659                          | 
|COCH-ARM / FISHERS |        P=0.425          P=0.247N         P=0.500N         P=0.306N         P=0.623                          | 
|ORDER RESTRICTED   |        P=0.267          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        27/50 (54%)      23/50 (46%)      26/50 (52%)      24/37 (65%)      17/32 (53%)                      | 
|POLY-3 RATE (b)    |        27/38.88         23/33.16         26/35.47         24/26.73         17/23.92                         | 
|POLY-3 PERCENT (g) |        69.5%            69.4%            73.3%            89.8%            71.1%                            | 
|TERMINAL (d)       |        15/19 (79%)      17/21 (81%)      9/13 (69%)       7/7 (100%)       4/8 (50%)                        | 
|FIRST INCIDENCE    |        322              432              229              301              229                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.015 *        P=0.229N         P=0.185          P=0.006 **       P=0.255                          | 
|POLY 3             |        P=0.171          P=0.607N         P=0.451          P=0.028 *        P=0.563                          | 
|POLY 1.5           |        P=0.165          P=0.512N         P=0.524          P=0.057          P=0.537                          | 
|POLY 6             |        P=0.225          P=0.596          P=0.424          P=0.022 *        P=0.628N                         | 
|LOGISTIC REGRESSION|        P=0.096          P=0.430N         P=0.475          P=0.050          P=0.480                          | 
|COCH-ARM / FISHERS |        P=0.247          P=0.274N         P=0.500N         P=0.213          P=0.559N                         | 
|ORDER RESTRICTED   |        P=0.238          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        7/50 (14%)       5/50 (10%)       7/40 (18%)       5/42 (12%)                       | 
|POLY-3 RATE (b)    |        2/35.79          7/35.16          5/37.71          7/32.90          5/31.34                          | 
|POLY-3 PERCENT (g) |        5.6%             19.9%            13.3%            21.3%            16.0%                            | 
|TERMINAL (d)       |        1/20 (5%)        2/18 (11%)       3/24 (13%)       4/20 (20%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        372              219              432              497              43                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.207          P=0.078          P=0.266          P=0.080          P=0.168                          | 
|POLY 3             |        P=0.170          P=0.069          P=0.235          P=0.055          P=0.160                          | 
|POLY 1.5           |        P=0.158          P=0.076          P=0.226          P=0.050          P=0.156                          | 
|POLY 6             |        P=0.187          P=0.062          P=0.252          P=0.060          P=0.168                          | 
|LOGISTIC REGRESSION|        P=0.130          P=0.086          P=0.219          P=0.047 *        P=0.164                          | 
|COCH-ARM / FISHERS |        P=0.139          P=0.080          P=0.218          P=0.038 *        P=0.152                          | 
|ORDER RESTRICTED   |        P=0.109          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Hydronephrosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        30/50 (60%)      20/50 (40%)      17/50 (34%)      16/37 (43%)      14/32 (44%)                      | 
|POLY-3 RATE (b)    |        30/42.16         20/37.16         17/36.51         16/25.32         14/24.87                         | 
|POLY-3 PERCENT (g) |        71.2%            53.8%            46.6%            63.2%            56.3%                            | 
|TERMINAL (d)       |        12/19 (63%)      10/21 (48%)      2/13 (15%)       4/7 (57%)        4/8 (50%)                        | 
|FIRST INCIDENCE    |        104              168              315              329              41                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.426          P=0.075N         P=0.154N         P=0.482          P=0.433N                         | 
|POLY 3             |        P=0.230N         P=0.074N         P=0.016N*        P=0.333N         P=0.152N                         | 
|POLY 1.5           |        P=0.209N         P=0.066N         P=0.013N*        P=0.239N         P=0.145N                         | 
|POLY 6             |        P=0.265N         P=0.075N         P=0.020N*        P=0.425N         P=0.169N                         | 
|LOGISTIC REGRESSION|        P=0.205N         P=0.045N*        P=0.010N*        P=0.142N         P=0.121N                         | 
|COCH-ARM / FISHERS |        P=0.173N         P=0.036N*        P=0.008N**       P=0.092N         P=0.113N                         | 
|ORDER RESTRICTED   |        P=0.137N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Hydronephrosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        7/50 (14%)       5/50 (10%)       5/40 (13%)       3/42 (7%)                        | 
|POLY-3 RATE (b)    |        2/34.96          7/33.14          5/39.05          5/32.78          3/30.44                          | 
|POLY-3 PERCENT (g) |        5.7%             21.1%            12.8%            15.3%            9.9%                             | 
|TERMINAL (d)       |        2/20 (10%)       3/18 (17%)       0/24 (0%)        2/20 (10%)       0/19 (0%)                        | 
|FIRST INCIDENCE    |        668 (T)          326              432              541              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.528N         P=0.053          P=0.266          P=0.213          P=0.449                          | 
|POLY 3             |        P=0.531          P=0.061          P=0.261          P=0.185          P=0.436                          | 
|POLY 1.5           |        P=0.508          P=0.070          P=0.241          P=0.171          P=0.428                          | 
|POLY 6             |        P=0.549N         P=0.055          P=0.292          P=0.201          P=0.447                          | 
|LOGISTIC REGRESSION|        P=0.472          P=0.065          P=0.216          P=0.181          P=0.421                          | 
|COCH-ARM / FISHERS |        P=0.470          P=0.080          P=0.218          P=0.136          P=0.417                          | 
|ORDER RESTRICTED   |        P=0.241          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)        1/37 (3%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        1/33.13          0/30.37          0/29.15          1/21.51          1/19.44                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             0.0%             4.7%             5.1%                             | 
|TERMINAL (d)       |        1/19 (5%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          ---              ---              501              593                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.210          P=0.480N         P=0.576N         P=0.613          P=0.595                          | 
|POLY 3             |        P=0.256          P=0.517N         P=0.526N         P=0.661          P=0.637                          | 
|POLY 1.5           |        P=0.254          P=0.516N         P=0.515N         P=0.671          P=0.639                          | 
|POLY 6             |        P=0.256          P=0.514N         P=0.539N         P=0.648          P=0.636                          | 
|LOGISTIC REGRESSION|        P=0.242          (e)              (e)              P=0.673          P=0.633                          | 
|COCH-ARM / FISHERS |        P=0.256          P=0.500N         P=0.500N         P=0.673          P=0.631                          | 
|ORDER RESTRICTED   |        P=0.325          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        3/50 (6%)        2/40 (5%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          1/31.04          3/37.71          2/32.58          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             8.0%             6.1%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        1/18 (6%)        1/24 (4%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              668 (T)          514              488              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.571N         P=0.479          P=0.137          P=0.237          (e)                              | 
|POLY 3             |        P=0.567          P=0.476          P=0.131          P=0.220          (e)                              | 
|POLY 1.5           |        P=0.554          P=0.488          P=0.126          P=0.211          (e)                              | 
|POLY 6             |        P=0.581          P=0.464          P=0.142          P=0.227          (e)                              | 
|LOGISTIC REGRESSION|        P=0.549          P=0.479          P=0.120          P=0.181          (e)                              | 
|COCH-ARM / FISHERS |        P=0.542          P=0.500          P=0.121          P=0.195          (e)                              | 
|ORDER RESTRICTED   |        P=0.251          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/50 (18%)       11/50 (22%)      17/50 (34%)      9/37 (24%)       12/32 (38%)                      | 
|POLY-3 RATE (b)    |        9/35.03          11/30.84         17/31.57         9/22.37          12/23.36                         | 
|POLY-3 PERCENT (g) |        25.7%            35.7%            53.9%            40.2%            51.4%                            | 
|TERMINAL (d)       |        5/19 (26%)       9/21 (43%)       9/13 (69%)       4/7 (57%)        3/8 (38%)                        | 
|FIRST INCIDENCE    |        322              580              538              531              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       P=0.445          P=0.007 **       P=0.062          P=0.017 *                        | 
|POLY 3             |        P=0.031 *        P=0.267          P=0.013 *        P=0.190          P=0.035 *                        | 
|POLY 1.5           |        P=0.030 *        P=0.295          P=0.022 *        P=0.231          P=0.031 *                        | 
|POLY 6             |        P=0.032 *        P=0.261          P=0.007 **       P=0.154          P=0.041 *                        | 
|LOGISTIC REGRESSION|        P=0.017 *        P=0.317          P=0.015 *        P=0.198          P=0.030 *                        | 
|COCH-ARM / FISHERS |        P=0.046 *        P=0.402          P=0.055          P=0.324          P=0.044 *                        | 
|ORDER RESTRICTED   |        P=0.031 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/50 (20%)      20/50 (40%)      15/50 (30%)      14/40 (35%)      15/42 (36%)                      | 
|POLY-3 RATE (b)    |        10/37.52         20/39.54         15/38.49         14/35.56         15/33.38                         | 
|POLY-3 PERCENT (g) |        26.7%            50.6%            39.0%            39.4%            44.9%                            | 
|TERMINAL (d)       |        4/20 (20%)       5/18 (28%)       9/24 (38%)       7/20 (35%)       7/19 (37%)                       | 
|FIRST INCIDENCE    |        372              326              425              359              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.309          P=0.021 *        P=0.314          P=0.223          P=0.110                          | 
|POLY 3             |        P=0.230          P=0.022 *        P=0.180          P=0.177          P=0.081                          | 
|POLY 1.5           |        P=0.192          P=0.023 *        P=0.177          P=0.149          P=0.072                          | 
|POLY 6             |        P=0.270          P=0.024 *        P=0.194          P=0.201          P=0.094                          | 
|LOGISTIC REGRESSION|        P=0.156          P=0.025 *        P=0.197          P=0.091          P=0.069                          | 
|COCH-ARM / FISHERS |        P=0.148          P=0.024 *        P=0.178          P=0.087          P=0.073                          | 
|ORDER RESTRICTED   |        P=0.088          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/50 (8%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        4/35.28          0/30.37          0/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        11.3%            0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        104              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.032N*        P=0.078N         P=0.091N         P=0.154N         P=0.161N                         | 
|POLY 3             |        P=0.019N*        P=0.080N         P=0.086N         P=0.149N         P=0.166N                         | 
|POLY 1.5           |        P=0.018N*        P=0.076N         P=0.076N         P=0.132N         P=0.158N                         | 
|POLY 6             |        P=0.021N*        P=0.080N         P=0.103N         P=0.173N         P=0.177N                         | 
|LOGISTIC REGRESSION|        P=0.020N*        P=0.044N*        P=0.049N*        P=0.080N         P=0.097N                         | 
|COCH-ARM / FISHERS |        P=0.024N*        P=0.059N         P=0.059N         P=0.103N         P=0.132N                         | 
|ORDER RESTRICTED   |        P=0.018N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          0/36.65          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        1/50 (2%)        2/37 (5%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        1/34.03          2/32.27          1/30.05          2/22.75          0/19.14                          | 
|POLY-3 PERCENT (g) |        2.9%             6.2%             3.3%             8.8%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        308              147              308              298              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.482N         P=0.474          P=0.747          P=0.372          P=0.607N                         | 
|POLY 3             |        P=0.518N         P=0.481          P=0.734          P=0.361          P=0.613N                         | 
|POLY 1.5           |        P=0.507N         P=0.482          P=0.744          P=0.373          P=0.608N                         | 
|POLY 6             |        P=0.530N         P=0.489          P=0.719          P=0.343          P=0.618N                         | 
|LOGISTIC REGRESSION|        P=0.332N         P=0.677          P=0.738N         P=0.498          P=0.499N                         | 
|COCH-ARM / FISHERS |        P=0.465N         P=0.500          P=0.753N         P=0.387          P=0.610N                         | 
|ORDER RESTRICTED   |        P=0.378N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        0/50 (0%)        0/50 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        3/35.88          0/31.04          0/36.65          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        8.4%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        2/20 (10%)       0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        287              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.035N*        P=0.132N         P=0.100N         P=0.130N         P=0.138N                         | 
|POLY 3             |        P=0.033N*        P=0.145N         P=0.113N         P=0.137N         P=0.159N                         | 
|POLY 1.5           |        P=0.036N*        P=0.132N         P=0.116N         P=0.143N         P=0.158N                         | 
|POLY 6             |        P=0.030N*        P=0.159N         P=0.108N         P=0.133N         P=0.160N                         | 
|LOGISTIC REGRESSION|        P=0.045N*        P=0.118N         P=0.123N         P=0.183N         P=0.151N                         | 
|COCH-ARM / FISHERS |        P=0.043N*        P=0.121N         P=0.121N         P=0.167N         P=0.156N                         | 
|ORDER RESTRICTED   |        P=0.009N**       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Metaplasia Osseous                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/50 (2%)        1/50 (2%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        1/33.13          1/30.37          1/29.53          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        3.0%             3.3%             3.4%             0.0%             0.0%                             | 
|TERMINAL (d)       |        1/19 (5%)        1/21 (5%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          668 (T)          570              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.298N         P=0.741N         P=0.700          P=0.699N         P=0.672N                         | 
|POLY 3             |        P=0.246N         P=0.742          P=0.736          P=0.590N         P=0.608N                         | 
|POLY 1.5           |        P=0.235N         P=0.744          P=0.745          P=0.580N         P=0.605N                         | 
|POLY 6             |        P=0.263N         P=0.747          P=0.723          P=0.604N         P=0.612N                         | 
|LOGISTIC REGRESSION|        P=0.246N         P=0.741N         P=0.732          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.218N         P=0.753N         P=0.753N         P=0.575N         P=0.610N                         | 
|ORDER RESTRICTED   |        P=0.424N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Metaplasia Osseous                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)        0/40 (0%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        1/35.25          0/31.04          0/36.65          0/31.97          2/28.91                          | 
|POLY-3 PERCENT (g) |        2.8%             0.0%             0.0%             0.0%             6.9%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        598              ---              ---              ---              645                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.174          P=0.564N         P=0.480N         P=0.514N         P=0.446                          | 
|POLY 3             |        P=0.191          P=0.525N         P=0.492N         P=0.520N         P=0.430                          | 
|POLY 1.5           |        P=0.179          P=0.513N         P=0.495N         P=0.525N         P=0.432                          | 
|POLY 6             |        P=0.200          P=0.539N         P=0.487N         P=0.517N         P=0.428                          | 
|LOGISTIC REGRESSION|        P=0.163          P=0.514N         P=0.496N         P=0.536N         P=0.432                          | 
|COCH-ARM / FISHERS |        P=0.153          P=0.500N         P=0.500N         P=0.556N         P=0.434                          | 
|ORDER RESTRICTED   |        P=0.052          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        40/50 (80%)      40/50 (80%)      42/50 (84%)      30/37 (81%)      23/32 (72%)                      | 
|POLY-3 RATE (b)    |        40/44.84         40/42.51         42/43.51         30/31.20         23/24.60                         | 
|POLY-3 PERCENT (g) |        89.2%            94.1%            96.5%            96.2%            93.5%                            | 
|TERMINAL (d)       |        17/19 (90%)      20/21 (95%)      13/13 (100%)     7/7 (100%)       7/8 (88%)                        | 
|FIRST INCIDENCE    |        111              157              147              301              404                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.120          P=0.551          P=0.076          P=0.047 *        P=0.361                          | 
|POLY 3             |        P=0.208          P=0.311          P=0.142          P=0.226          P=0.432                          | 
|POLY 1.5           |        P=0.338          P=0.367          P=0.201          P=0.275          P=0.536                          | 
|POLY 6             |        P=0.194          P=0.297          P=0.127          P=0.232          P=0.425                          | 
|LOGISTIC REGRESSION|        P=0.400N         P=0.396          P=0.248          P=0.339          P=0.497N                         | 
|COCH-ARM / FISHERS |        P=0.238N         P=0.598N         P=0.398          P=0.562          P=0.278N                         | 
|ORDER RESTRICTED   |        P=0.222          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        29/50 (58%)      31/50 (62%)      41/50 (82%)      26/40 (65%)      33/42 (79%)                      | 
|POLY-3 RATE (b)    |        29/43.26         31/45.61         41/47.70         26/38.11         33/40.07                         | 
|POLY-3 PERCENT (g) |        67.0%            68.0%            86.0%            68.2%            82.4%                            | 
|TERMINAL (d)       |        12/20 (60%)      7/18 (39%)       20/24 (83%)      11/20 (55%)      14/19 (74%)                      | 
|FIRST INCIDENCE    |        248              207              237              359              43                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.310          P=0.244          P=0.152          P=0.458N         P=0.134                          | 
|POLY 3             |        P=0.111          P=0.555          P=0.022 *        P=0.551          P=0.077                          | 
|POLY 1.5           |        P=0.080          P=0.525          P=0.012 *        P=0.486          P=0.056                          | 
|POLY 6             |        P=0.156          P=0.595          P=0.046 *        P=0.590N         P=0.116                          | 
|LOGISTIC REGRESSION|        P=0.033 *        P=0.459          P=0.009 **       P=0.321          P=0.031 *                        | 
|COCH-ARM / FISHERS |        P=0.038 *        P=0.419          P=0.008 **       P=0.324          P=0.030 *                        | 
|ORDER RESTRICTED   |        P=0.074          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          0/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        2/50 (4%)        3/40 (8%)        3/42 (7%)                        | 
|POLY-3 RATE (b)    |        1/35.38          2/31.50          2/37.65          3/32.64          3/29.94                          | 
|POLY-3 PERCENT (g) |        2.8%             6.4%             5.3%             9.2%             10.0%                            | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        558              577              524              510              530                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.138          P=0.402          P=0.497          P=0.288          P=0.225                          | 
|POLY 3             |        P=0.133          P=0.459          P=0.522          P=0.274          P=0.245                          | 
|POLY 1.5           |        P=0.124          P=0.479          P=0.513          P=0.263          P=0.242                          | 
|POLY 6             |        P=0.141          P=0.439          P=0.537          P=0.283          P=0.251                          | 
|LOGISTIC REGRESSION|        P=0.113          P=0.478          P=0.494          P=0.236          P=0.243                          | 
|COCH-ARM / FISHERS |        P=0.112          P=0.500          P=0.500          P=0.229          P=0.245                          | 
|ORDER RESTRICTED   |        P=0.212          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        5/50 (10%)       2/37 (5%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        0/33.13          1/31.13          5/32.45          2/21.97          1/19.62                          | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             15.4%            9.1%             5.1%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              418              376              434              539                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.244          P=0.480          P=0.033 *        P=0.150          P=0.402                          | 
|POLY 3             |        P=0.215          P=0.488          P=0.027 *        P=0.151          P=0.396                          | 
|POLY 1.5           |        P=0.221          P=0.487          P=0.028 *        P=0.157          P=0.397                          | 
|POLY 6             |        P=0.206          P=0.493          P=0.025 *        P=0.144          P=0.395                          | 
|LOGISTIC REGRESSION|        P=0.278          P=0.536          P=0.039 *        P=0.179          P=0.409                          | 
|COCH-ARM / FISHERS |        P=0.258          P=0.500          P=0.028 *        P=0.178          P=0.390                          | 
|ORDER RESTRICTED   |        P=0.124          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        3/50 (6%)        0/50 (0%)        1/40 (3%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        1/34.96          3/32.90          0/36.65          1/32.58          0/28.81                          | 
|POLY-3 PERCENT (g) |        2.9%             9.1%             0.0%             3.1%             0.0%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        668 (T)          417              ---              488              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.173N         P=0.273          P=0.464N         P=0.757          P=0.510N                         | 
|POLY 3             |        P=0.199N         P=0.282          P=0.491N         P=0.746          P=0.539N                         | 
|POLY 1.5           |        P=0.196N         P=0.294          P=0.494N         P=0.737          P=0.538N                         | 
|POLY 6             |        P=0.203N         P=0.272          P=0.483N         P=0.754          P=0.539N                         | 
|LOGISTIC REGRESSION|        P=0.198N         P=0.312          (e)              P=0.712          (e)                              | 
|COCH-ARM / FISHERS |        P=0.190N         P=0.309          P=0.500N         P=0.694          P=0.543N                         | 
|ORDER RESTRICTED   |        P=0.146N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        0/50 (0%)        0/50 (0%)        1/37 (3%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        3/34.31          0/30.37          0/29.15          1/21.09          0/19.14                          | 
|POLY-3 PERCENT (g) |        8.7%             0.0%             0.0%             4.7%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        392              ---              ---              631              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.209N         P=0.148N         P=0.169N         P=0.558N         P=0.263N                         | 
|POLY 3             |        P=0.155N         P=0.140N         P=0.148N         P=0.491N         P=0.242N                         | 
|POLY 1.5           |        P=0.154N         P=0.136N         P=0.136N         P=0.464N         P=0.234N                         | 
|POLY 6             |        P=0.160N         P=0.140N         P=0.168N         P=0.525N         P=0.253N                         | 
|LOGISTIC REGRESSION|        P=0.171N         P=0.122N         P=0.122N         P=0.440N         P=0.211N                         | 
|COCH-ARM / FISHERS |        P=0.162N         P=0.121N         P=0.121N         P=0.429N         P=0.221N                         | 
|ORDER RESTRICTED   |        P=0.070N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        1/50 (2%)        1/40 (3%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          1/36.85          1/32.73          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.7%             3.1%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              619              414              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.503          (e)              P=0.551          P=0.485          (e)                              | 
|POLY 3             |        P=0.502          (e)              P=0.511          P=0.487          (e)                              | 
|POLY 1.5           |        P=0.491          (e)              P=0.506          P=0.479          (e)                              | 
|POLY 6             |        P=0.516          (e)              P=0.519          P=0.493          (e)                              | 
|LOGISTIC REGRESSION|        P=0.474          (e)              P=0.507          P=0.293          (e)                              | 
|COCH-ARM / FISHERS |        P=0.479          (e)              P=0.500          P=0.444          (e)                              | 
|ORDER RESTRICTED   |        P=0.413          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        2/50 (4%)        2/37 (5%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          1/30.37          2/29.86          2/21.81          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             3.3%             6.7%             9.2%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              668 (T)          544              434              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.366          P=0.520          P=0.202          P=0.124          (e)                              | 
|POLY 3             |        P=0.383          P=0.483          P=0.213          P=0.150          (e)                              | 
|POLY 1.5           |        P=0.390          P=0.484          P=0.222          P=0.157          (e)                              | 
|POLY 6             |        P=0.372          P=0.486          P=0.204          P=0.142          (e)                              | 
|LOGISTIC REGRESSION|        P=0.409          P=0.520          P=0.224          P=0.172          (e)                              | 
|COCH-ARM / FISHERS |        P=0.428          P=0.500          P=0.247          P=0.178          (e)                              | 
|ORDER RESTRICTED   |        P=0.290          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/50 (2%)        1/50 (2%)        2/40 (5%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        1/35.26          1/31.40          1/37.13          2/32.61          2/29.41                          | 
|POLY-3 PERCENT (g) |        2.8%             3.2%             2.7%             6.1%             6.8%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        593              577              537              565              593                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.207          P=0.675          P=0.753N         P=0.466          P=0.422                          | 
|POLY 3             |        P=0.205          P=0.735          P=0.750N         P=0.472          P=0.436                          | 
|POLY 1.5           |        P=0.196          P=0.748          P=0.754N         P=0.460          P=0.435                          | 
|POLY 6             |        P=0.215          P=0.721          P=0.742N         P=0.484          P=0.440                          | 
|LOGISTIC REGRESSION|        P=0.183          P=0.753          P=0.762          P=0.426          P=0.435                          | 
|COCH-ARM / FISHERS |        P=0.180          P=0.753N         P=0.753N         P=0.416          P=0.434                          | 
|ORDER RESTRICTED   |        P=0.386          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        4/50 (8%)        2/50 (4%)        2/37 (5%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        2/33.13          4/30.37          2/29.39          2/21.55          0/19.14                          | 
|POLY-3 PERCENT (g) |        6.0%             13.2%            6.8%             9.3%             0.0%                             | 
|TERMINAL (d)       |        2/19 (11%)       4/21 (19%)       0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          668 (T)          633              580              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.363N         P=0.380          P=0.557          P=0.423          P=0.442N                         | 
|POLY 3             |        P=0.231N         P=0.294          P=0.652          P=0.532          P=0.366N                         | 
|POLY 1.5           |        P=0.223N         P=0.299          P=0.668          P=0.548          P=0.362N                         | 
|POLY 6             |        P=0.242N         P=0.300          P=0.631          P=0.515          P=0.371N                         | 
|LOGISTIC REGRESSION|        P=0.257N         P=0.380          P=0.595          P=0.503          (e)                              | 
|COCH-ARM / FISHERS |        P=0.195N         P=0.339          P=0.691N         P=0.571          P=0.369N                         | 
|ORDER RESTRICTED   |        P=0.208N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        1/50 (2%)        0/40 (0%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          1/36.66          0/31.97          1/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.7%             0.0%             3.5%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        ---              ---              666              ---              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.267          (e)              P=0.545          (e)              P=0.490                          | 
|POLY 3             |        P=0.281          (e)              P=0.509          (e)              P=0.461                          | 
|POLY 1.5           |        P=0.266          (e)              P=0.506          (e)              P=0.462                          | 
|POLY 6             |        P=0.295          (e)              P=0.517          (e)              P=0.461                          | 
|LOGISTIC REGRESSION|        P=0.260          (e)              P=0.537          (e)              P=0.490                          | 
|COCH-ARM / FISHERS |        P=0.235          (e)              P=0.500          (e)              P=0.457                          | 
|ORDER RESTRICTED   |        P=0.183          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)        1/37 (3%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          2/29.85          1/21.38          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             6.7%             4.7%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              510              549              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.442          (e)              P=0.194          P=0.422          (e)                              | 
|POLY 3             |        P=0.432          (e)              P=0.213          P=0.413          (e)                              | 
|POLY 1.5           |        P=0.437          (e)              P=0.222          P=0.422          (e)                              | 
|POLY 6             |        P=0.423          (e)              P=0.203          P=0.403          (e)                              | 
|LOGISTIC REGRESSION|        P=0.456          (e)              P=0.225          P=0.434          (e)                              | 
|COCH-ARM / FISHERS |        P=0.467          (e)              P=0.247          P=0.425          (e)                              | 
|ORDER RESTRICTED   |        P=0.306          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        1/50 (2%)        1/40 (3%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        2/35.19          0/31.04          1/36.65          1/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        5.7%             0.0%             2.7%             3.1%             0.0%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        1/24 (4%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        612              ---              668 (T)          668 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.218N         P=0.276N         P=0.429N         P=0.500N         P=0.265N                         | 
|POLY 3             |        P=0.248N         P=0.265N         P=0.486N         P=0.534N         P=0.282N                         | 
|POLY 1.5           |        P=0.258N         P=0.251N         P=0.491N         P=0.543N         P=0.281N                         | 
|POLY 6             |        P=0.240N         P=0.282N         P=0.476N         P=0.528N         P=0.283N                         | 
|LOGISTIC REGRESSION|        P=0.230N         P=0.275N         P=0.468N         P=0.521N         P=0.280N                         | 
|COCH-ARM / FISHERS |        P=0.261N         P=0.247N         P=0.500N         P=0.584N         P=0.293N                         | 
|ORDER RESTRICTED   |        P=0.122N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        2/50 (4%)        2/50 (4%)        1/37 (3%)        2/32 (6%)                        | 
|POLY-3 RATE (b)    |        3/34.22          2/30.37          2/29.84          1/21.09          2/19.44                          | 
|POLY-3 PERCENT (g) |        8.8%             6.6%             6.7%             4.7%             10.3%                            | 
|TERMINAL (d)       |        1/19 (5%)        2/21 (10%)       0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        446              668 (T)          490              631              627                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.444          P=0.494N         P=0.589N         P=0.557N         P=0.593                          | 
|POLY 3             |        P=0.543          P=0.555N         P=0.563N         P=0.490N         P=0.617                          | 
|POLY 1.5           |        P=0.557          P=0.544N         P=0.538N         P=0.463N         P=0.626                          | 
|POLY 6             |        P=0.521          P=0.557N         P=0.595N         P=0.523N         P=0.608                          | 
|LOGISTIC REGRESSION|        P=0.545          P=0.532N         P=0.518N         P=0.448N         P=0.638                          | 
|COCH-ARM / FISHERS |        P=0.540N         P=0.500N         P=0.500N         P=0.429N         P=0.652                          | 
|ORDER RESTRICTED   |        P=0.583          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        3/50 (6%)        1/40 (3%)        3/42 (7%)                        | 
|POLY-3 RATE (b)    |        1/34.96          2/31.46          3/37.39          1/32.58          3/29.89                          | 
|POLY-3 PERCENT (g) |        2.9%             6.4%             8.0%             3.1%             10.0%                            | 
|TERMINAL (d)       |        1/20 (5%)        1/18 (6%)        1/24 (4%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        668 (T)          559              514              488              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.283          P=0.446          P=0.363          P=0.757          P=0.267                          | 
|POLY 3             |        P=0.288          P=0.463          P=0.328          P=0.746          P=0.248                          | 
|POLY 1.5           |        P=0.269          P=0.481          P=0.318          P=0.737          P=0.244                          | 
|POLY 6             |        P=0.306          P=0.445          P=0.347          P=0.754          P=0.254                          | 
|LOGISTIC REGRESSION|        P=0.239          P=0.446          P=0.317          P=0.712          P=0.241                          | 
|COCH-ARM / FISHERS |        P=0.233          P=0.500          P=0.309          P=0.694          P=0.245                          | 
|ORDER RESTRICTED   |        P=0.196          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/50 (18%)       7/50 (14%)       12/50 (24%)      6/37 (16%)       5/32 (16%)                       | 
|POLY-3 RATE (b)    |        9/37.84          7/35.33          12/35.05         6/24.88          5/21.68                          | 
|POLY-3 PERCENT (g) |        23.8%            19.8%            34.2%            24.1%            23.1%                            | 
|TERMINAL (d)       |        1/19 (5%)        0/21 (0%)        2/13 (15%)       0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        111              157              229              298              192                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.470          P=0.459N         P=0.199          P=0.537          P=0.587N                         | 
|POLY 3             |        P=0.508          P=0.449N         P=0.230          P=0.607          P=0.599N                         | 
|POLY 1.5           |        P=0.531N         P=0.443N         P=0.263          P=0.594N         P=0.581N                         | 
|POLY 6             |        P=0.454          P=0.447N         P=0.183          P=0.553          P=0.625N                         | 
|LOGISTIC REGRESSION|        P=0.375N         P=0.274N         P=0.375          P=0.417N         P=0.434N                         | 
|COCH-ARM / FISHERS |        P=0.456N         P=0.393N         P=0.312          P=0.531N         P=0.515N                         | 
|ORDER RESTRICTED   |        P=0.534          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/50 (16%)       5/50 (10%)       5/50 (10%)       5/40 (13%)       8/42 (19%)                       | 
|POLY-3 RATE (b)    |        8/38.10          5/34.04          5/38.64          5/33.23          8/31.44                          | 
|POLY-3 PERCENT (g) |        21.0%            14.7%            12.9%            15.0%            25.4%                            | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        1/24 (4%)        2/20 (10%)       3/19 (16%)                       | 
|FIRST INCIDENCE    |        179              207              182              414              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.355          P=0.379N         P=0.226N         P=0.324N         P=0.474                          | 
|POLY 3             |        P=0.317          P=0.348N         P=0.261N         P=0.365N         P=0.439                          | 
|POLY 1.5           |        P=0.295          P=0.312N         P=0.266N         P=0.378N         P=0.437                          | 
|POLY 6             |        P=0.332          P=0.387N         P=0.253N         P=0.363N         P=0.445                          | 
|LOGISTIC REGRESSION|        P=0.250          P=0.252N         P=0.291N         P=0.510N         P=0.459                          | 
|COCH-ARM / FISHERS |        P=0.265          P=0.277N         P=0.277N         P=0.437N         P=0.455                          | 
|ORDER RESTRICTED   |        P=0.262          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 43      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        1/50 (2%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          1/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             3.4%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              668 (T)          ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.663          (e)              P=0.424          (e)              (e)                              | 
|POLY 3             |        P=0.680N         (e)              P=0.474          (e)              (e)                              | 
|POLY 1.5           |        P=0.665N         (e)              P=0.485          (e)              (e)                              | 
|POLY 6             |        P=0.700N         (e)              P=0.461          (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.424          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.647N         (e)              P=0.500          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.512          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        3/40 (8%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          0/36.65          3/32.44          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             9.3%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        2/20 (10%)       0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              541              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.174          (e)              (e)              P=0.113          (e)                              | 
|POLY 3             |        P=0.133          (e)              (e)              P=0.103          (e)                              | 
|POLY 1.5           |        P=0.134          (e)              (e)              P=0.097          (e)                              | 
|POLY 6             |        P=0.133          (e)              (e)              P=0.108          (e)                              | 
|LOGISTIC REGRESSION|        P=0.161          (e)              (e)              P=0.101          (e)                              | 
|COCH-ARM / FISHERS |        P=0.153          (e)              (e)              P=0.084          (e)                              | 
|ORDER RESTRICTED   |        P=0.119          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 44      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/50 (20%)      7/50 (14%)       2/50 (4%)        5/37 (14%)       2/32 (6%)                        | 
|POLY-3 RATE (b)    |        10/35.49         7/30.89          2/29.65          5/21.36          2/19.75                          | 
|POLY-3 PERCENT (g) |        28.2%            22.7%            6.8%             23.4%            10.1%                            | 
|TERMINAL (d)       |        6/19 (32%)       6/21 (29%)       0/13 (0%)        3/7 (43%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        308              523              606              608              488                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.243N         P=0.264N         P=0.052N         P=0.527          P=0.180N                         | 
|POLY 3             |        P=0.086N         P=0.407N         P=0.026N*        P=0.467N         P=0.111N                         | 
|POLY 1.5           |        P=0.080N         P=0.384N         P=0.020N*        P=0.407N         P=0.105N                         | 
|POLY 6             |        P=0.095N         P=0.408N         P=0.034N*        P=0.539N         P=0.118N                         | 
|LOGISTIC REGRESSION|        P=0.099N         P=0.356N         P=0.021N*        P=0.412N         P=0.097N                         | 
|COCH-ARM / FISHERS |        P=0.072N         P=0.298N         P=0.014N*        P=0.310N         P=0.077N                         | 
|ORDER RESTRICTED   |        P=0.093N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       6/50 (12%)       6/50 (12%)       9/40 (23%)       9/42 (21%)                       | 
|POLY-3 RATE (b)    |        7/35.41          6/33.58          6/37.69          9/33.46          9/29.89                          | 
|POLY-3 PERCENT (g) |        19.8%            17.9%            15.9%            26.9%            30.1%                            | 
|TERMINAL (d)       |        4/20 (20%)       1/18 (6%)        4/24 (17%)       4/20 (20%)       5/19 (26%)                       | 
|FIRST INCIDENCE    |        588              369              460              530              539                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.142          P=0.605N         P=0.392N         P=0.385          P=0.305                          | 
|POLY 3             |        P=0.088          P=0.543N         P=0.451N         P=0.338          P=0.245                          | 
|POLY 1.5           |        P=0.079          P=0.518N         P=0.471N         P=0.302          P=0.243                          | 
|POLY 6             |        P=0.099          P=0.566N         P=0.419N         P=0.375          P=0.253                          | 
|LOGISTIC REGRESSION|        P=0.086          P=0.555N         P=0.455N         P=0.317          P=0.229                          | 
|COCH-ARM / FISHERS |        P=0.071          P=0.500N         P=0.500N         P=0.220          P=0.254                          | 
|ORDER RESTRICTED   |        P=0.198          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 45      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/50 (16%)       9/50 (18%)       7/50 (14%)       4/37 (11%)       3/32 (9%)                        | 
|POLY-3 RATE (b)    |        8/34.88          9/33.08          7/31.07          4/22.82          3/19.74                          | 
|POLY-3 PERCENT (g) |        22.9%            27.2%            22.5%            17.5%            15.2%                            | 
|TERMINAL (d)       |        3/19 (16%)       3/21 (14%)       2/13 (15%)       1/7 (14%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        463              254              243              157              538                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.325N         P=0.487          P=0.496          P=0.582N         P=0.434N                         | 
|POLY 3             |        P=0.190N         P=0.449          P=0.601N         P=0.436N         P=0.370N                         | 
|POLY 1.5           |        P=0.172N         P=0.450          P=0.558N         P=0.401N         P=0.355N                         | 
|POLY 6             |        P=0.225N         P=0.468          P=0.575          P=0.485N         P=0.392N                         | 
|LOGISTIC REGRESSION|        P=0.163N         P=0.446          P=0.571N         P=0.390N         P=0.352N                         | 
|COCH-ARM / FISHERS |        P=0.138N         P=0.500          P=0.500N         P=0.357N         P=0.305N                         | 
|ORDER RESTRICTED   |        P=0.382N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       8/50 (16%)       5/50 (10%)       4/40 (10%)       6/42 (14%)                       | 
|POLY-3 RATE (b)    |        6/36.84          8/34.89          5/37.43          4/33.22          6/29.23                          | 
|POLY-3 PERCENT (g) |        16.3%            22.9%            13.4%            12.0%            20.5%                            | 
|TERMINAL (d)       |        3/20 (15%)       1/18 (6%)        2/24 (8%)        1/20 (5%)        4/19 (21%)                       | 
|FIRST INCIDENCE    |        255              369              524              414              585                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.431N         P=0.292          P=0.416N         P=0.418N         P=0.530                          | 
|POLY 3             |        P=0.504N         P=0.339          P=0.489N         P=0.434N         P=0.451                          | 
|POLY 1.5           |        P=0.512N         P=0.360          P=0.496N         P=0.453N         P=0.463                          | 
|POLY 6             |        P=0.502N         P=0.330          P=0.468N         P=0.419N         P=0.442                          | 
|LOGISTIC REGRESSION|        P=0.517N         P=0.396          P=0.491N         P=0.562N         P=0.484                          | 
|COCH-ARM / FISHERS |        P=0.528N         P=0.387          P=0.500N         P=0.519N         P=0.492                          | 
|ORDER RESTRICTED   |        P=0.550N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 46      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        1/50 (2%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        2/33.99          0/30.37          1/29.77          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        5.9%             0.0%             3.4%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        475              ---              482              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.159N         P=0.266N         P=0.548N         P=0.364N         P=0.363N                         | 
|POLY 3             |        P=0.151N         P=0.262N         P=0.546N         P=0.352N         P=0.373N                         | 
|POLY 1.5           |        P=0.145N         P=0.257N         P=0.528N         P=0.335N         P=0.365N                         | 
|POLY 6             |        P=0.164N         P=0.262N         P=0.571N         P=0.376N         P=0.383N                         | 
|LOGISTIC REGRESSION|        P=0.143N         P=0.240N         P=0.495N         P=0.309N         P=0.343N                         | 
|COCH-ARM / FISHERS |        P=0.143N         P=0.247N         P=0.500N         P=0.327N         P=0.369N                         | 
|ORDER RESTRICTED   |        P=0.163N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          0/36.65          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 47      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/50 (30%)      15/50 (30%)      9/50 (18%)       6/37 (16%)       15/32 (47%)                      | 
|POLY-3 RATE (b)    |        15/35.89         15/33.83         9/33.41          6/22.46          15/23.78                         | 
|POLY-3 PERCENT (g) |        41.8%            44.3%            26.9%            26.7%            63.1%                            | 
|TERMINAL (d)       |        8/19 (42%)       10/21 (48%)      1/13 (8%)        0/7 (0%)         6/8 (75%)                        | 
|FIRST INCIDENCE    |        322              254              229              563              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.038 *        P=0.561N         P=0.336N         P=0.417N         P=0.027 *                        | 
|POLY 3             |        P=0.118          P=0.511          P=0.140N         P=0.184N         P=0.076                          | 
|POLY 1.5           |        P=0.130          P=0.516          P=0.128N         P=0.155N         P=0.070                          | 
|POLY 6             |        P=0.106          P=0.521          P=0.166N         P=0.217N         P=0.081                          | 
|LOGISTIC REGRESSION|        P=0.140          P=0.493          P=0.146N         P=0.179N         P=0.054                          | 
|COCH-ARM / FISHERS |        P=0.190          P=0.586N         P=0.121N         P=0.108N         P=0.095                          | 
|ORDER RESTRICTED   |        P=0.023 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        6/50 (12%)       3/50 (6%)        2/40 (5%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        1/35.32          6/35.10          3/37.76          2/32.44          2/29.28                          | 
|POLY-3 PERCENT (g) |        2.8%             17.1%            7.9%             6.2%             6.8%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        577              326              362              608              539                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.413N         P=0.047 *        P=0.347          P=0.478          P=0.435                          | 
|POLY 3             |        P=0.434N         P=0.051          P=0.328          P=0.470          P=0.434                          | 
|POLY 1.5           |        P=0.440N         P=0.055          P=0.319          P=0.458          P=0.434                          | 
|POLY 6             |        P=0.430N         P=0.048 *        P=0.343          P=0.480          P=0.435                          | 
|LOGISTIC REGRESSION|        P=0.468N         P=0.060          P=0.302          P=0.438          P=0.435                          | 
|COCH-ARM / FISHERS |        P=0.453N         P=0.056          P=0.309          P=0.416          P=0.434                          | 
|ORDER RESTRICTED   |        P=0.286          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 48      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/50 (2%)        2/50 (4%)        0/37 (0%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        1/33.32          1/30.37          2/30.05          0/20.93          1/19.79                          | 
|POLY-3 PERCENT (g) |        3.0%             3.3%             6.7%             0.0%             5.1%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        621              668 (T)          315              ---              473                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.519          P=0.754N         P=0.416          P=0.622N         P=0.652                          | 
|POLY 3             |        P=0.571          P=0.741          P=0.464          P=0.591N         P=0.640                          | 
|POLY 1.5           |        P=0.580          P=0.743          P=0.479          P=0.580N         P=0.641                          | 
|POLY 6             |        P=0.556          P=0.744          P=0.442          P=0.606N         P=0.639                          | 
|LOGISTIC REGRESSION|        P=0.581N         P=0.749          P=0.500          P=0.597N         P=0.656                          | 
|COCH-ARM / FISHERS |        P=0.572N         P=0.753N         P=0.500          P=0.575N         P=0.631                          | 
|ORDER RESTRICTED   |        P=0.616          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        3/50 (6%)        0/40 (0%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        0/34.96          1/31.32          3/37.67          0/31.97          2/29.97                          | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             8.0%             0.0%             6.7%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        1/24 (4%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              600              514              ---              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.275          P=0.457          P=0.137          (e)              P=0.192                          | 
|POLY 3             |        P=0.305          P=0.478          P=0.131          (e)              P=0.202                          | 
|POLY 1.5           |        P=0.287          P=0.489          P=0.126          (e)              P=0.200                          | 
|POLY 6             |        P=0.322          P=0.467          P=0.141          (e)              P=0.205                          | 
|LOGISTIC REGRESSION|        P=0.245          P=0.485          P=0.121          (e)              P=0.210                          | 
|COCH-ARM / FISHERS |        P=0.249          P=0.500          P=0.121          (e)              P=0.206                          | 
|ORDER RESTRICTED   |        P=0.126          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 49      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Kupffer Cell                                                                                                              | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        0/50 (0%)        1/37 (3%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        2/33.47          0/30.37          0/29.15          1/20.96          1/19.28                          | 
|POLY-3 PERCENT (g) |        6.0%             0.0%             0.0%             4.8%             5.2%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        619              ---              ---              662              635                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.406          P=0.254N         P=0.326N         P=0.701          P=0.687N                         | 
|POLY 3             |        P=0.498          P=0.258N         P=0.268N         P=0.659N         P=0.687N                         | 
|POLY 1.5           |        P=0.497          P=0.255N         P=0.255N         P=0.639N         P=0.681N                         | 
|POLY 6             |        P=0.495          P=0.256N         P=0.287N         P=0.685N         P=0.695N                         | 
|LOGISTIC REGRESSION|        P=0.451          P=0.254N         P=0.273N         P=0.690N         P=0.692N                         | 
|COCH-ARM / FISHERS |        P=0.495          P=0.247N         P=0.247N         P=0.613N         P=0.779                          | 
|ORDER RESTRICTED   |        P=0.394N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Kupffer Cell                                                                                                              | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        1/50 (2%)        1/40 (3%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        1/34.96          0/31.04          1/36.65          1/32.49          2/30.40                          | 
|POLY-3 PERCENT (g) |        2.9%             0.0%             2.7%             3.1%             6.6%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        1/24 (4%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        668 (T)          ---              668 (T)          523              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.170          P=0.521N         P=0.722N         P=0.751          P=0.447                          | 
|POLY 3             |        P=0.187          P=0.524N         P=0.751N         P=0.746          P=0.451                          | 
|POLY 1.5           |        P=0.173          P=0.512N         P=0.755N         P=0.737          P=0.446                          | 
|POLY 6             |        P=0.201          P=0.536N         P=0.743N         P=0.754          P=0.457                          | 
|LOGISTIC REGRESSION|        P=0.146          (e)              P=0.722N         P=0.723          P=0.461                          | 
|COCH-ARM / FISHERS |        P=0.148          P=0.500N         P=0.753N         P=0.694          P=0.434                          | 
|ORDER RESTRICTED   |        P=0.200          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 50      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Kupffer Cell                                                                                                              | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        3/50 (6%)        0/50 (0%)        2/37 (5%)        3/32 (9%)                        | 
|POLY-3 RATE (b)    |        2/33.19          3/30.37          0/29.15          2/22.07          3/19.89                          | 
|POLY-3 PERCENT (g) |        6.0%             9.9%             0.0%             9.1%             15.1%                            | 
|TERMINAL (d)       |        1/19 (5%)        3/21 (14%)       0/13 (0%)        0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        654              668 (T)          ---              157              488                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.087          P=0.537          P=0.338N         P=0.416          P=0.211                          | 
|POLY 3             |        P=0.166          P=0.459          P=0.266N         P=0.541          P=0.273                          | 
|POLY 1.5           |        P=0.170          P=0.464          P=0.254N         P=0.557          P=0.274                          | 
|POLY 6             |        P=0.162          P=0.466          P=0.282N         P=0.519          P=0.273                          | 
|LOGISTIC REGRESSION|        P=0.162          P=0.500          P=0.309N         P=0.587          P=0.258                          | 
|COCH-ARM / FISHERS |        P=0.184          P=0.500          P=0.247N         P=0.571          P=0.296                          | 
|ORDER RESTRICTED   |        P=0.184          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Kupffer Cell                                                                                                              | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/50 (8%)        4/50 (8%)        2/50 (4%)        6/40 (15%)       6/42 (14%)                       | 
|POLY-3 RATE (b)    |        4/36.27          4/32.56          2/37.00          6/33.02          6/30.88                          | 
|POLY-3 PERCENT (g) |        11.0%            12.3%            5.4%             18.2%            19.4%                            | 
|TERMINAL (d)       |        1/20 (5%)        1/18 (6%)        0/24 (0%)        3/20 (15%)       3/19 (16%)                       | 
|FIRST INCIDENCE    |        248              500              621              523              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.116          P=0.550          P=0.285N         P=0.349          P=0.289                          | 
|POLY 3             |        P=0.091          P=0.584          P=0.326N         P=0.306          P=0.266                          | 
|POLY 1.5           |        P=0.084          P=0.611          P=0.332N         P=0.288          P=0.263                          | 
|POLY 6             |        P=0.097          P=0.561          P=0.311N         P=0.323          P=0.271                          | 
|LOGISTIC REGRESSION|        P=0.074          P=0.644N         P=0.336N         P=0.242          P=0.269                          | 
|COCH-ARM / FISHERS |        P=0.073          P=0.643N         P=0.339N         P=0.237          P=0.264                          | 
|ORDER RESTRICTED   |        P=0.189          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 51      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        2/50 (4%)        4/37 (11%)       0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          1/30.37          2/29.55          4/21.96          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             3.3%             6.8%             18.2%            0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              668 (T)          606              580              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.166          P=0.520          P=0.179          P=0.020 *        (e)                              | 
|POLY 3             |        P=0.166          P=0.483          P=0.211          P=0.019 *        (e)                              | 
|POLY 1.5           |        P=0.172          P=0.484          P=0.221          P=0.022 *        (e)                              | 
|POLY 6             |        P=0.155          P=0.486          P=0.200          P=0.018 *        (e)                              | 
|LOGISTIC REGRESSION|        P=0.176          P=0.520          P=0.204          P=0.020 *        (e)                              | 
|COCH-ARM / FISHERS |        P=0.205          P=0.500          P=0.247          P=0.030 *        (e)                              | 
|ORDER RESTRICTED   |        P=0.125          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        3/49 (6%)        4/50 (8%)        1/40 (3%)        3/42 (7%)                        | 
|POLY-3 RATE (b)    |        1/35.82          3/32.64          4/37.37          1/32.81          3/31.17                          | 
|POLY-3 PERCENT (g) |        2.8%             9.2%             10.7%            3.1%             9.6%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        352              417              585              359              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.389          P=0.282          P=0.229          P=0.737          P=0.249                          | 
|POLY 3             |        P=0.409          P=0.271          P=0.189          P=0.743          P=0.254                          | 
|POLY 1.5           |        P=0.389          P=0.285          P=0.184          P=0.735          P=0.250                          | 
|POLY 6             |        P=0.425          P=0.258          P=0.204          P=0.748          P=0.260                          | 
|LOGISTIC REGRESSION|        P=0.335          P=0.296          P=0.179          P=0.453          P=0.284                          | 
|COCH-ARM / FISHERS |        P=0.345          P=0.301          P=0.181          P=0.694          P=0.245                          | 
|ORDER RESTRICTED   |        P=0.238          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 52      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        1/50 (2%)        1/37 (3%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        1/33.19          0/30.37          1/29.79          1/21.33          1/20.14                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             3.4%             4.7%             5.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        654              ---              474              563              41                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.272          P=0.500N         P=0.708          P=0.605          P=0.624                          | 
|POLY 3             |        P=0.306          P=0.518N         P=0.737          P=0.658          P=0.646                          | 
|POLY 1.5           |        P=0.307          P=0.516N         P=0.746          P=0.670          P=0.648                          | 
|POLY 6             |        P=0.300          P=0.515N         P=0.725          P=0.644          P=0.643                          | 
|LOGISTIC REGRESSION|        P=0.333          P=0.510N         P=0.755          P=0.661          P=0.753                          | 
|COCH-ARM / FISHERS |        P=0.305          P=0.500N         P=0.753N         P=0.673          P=0.631                          | 
|ORDER RESTRICTED   |        P=0.443          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        0/49 (0%)        0/50 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        3/35.75          0/30.96          0/36.65          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        8.4%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        577              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.039N*        P=0.191N         P=0.113N         P=0.153N         P=0.171N                         | 
|POLY 3             |        P=0.034N*        P=0.145N         P=0.113N         P=0.137N         P=0.158N                         | 
|POLY 1.5           |        P=0.037N*        P=0.132N         P=0.115N         P=0.141N         P=0.156N                         | 
|POLY 6             |        P=0.031N*        P=0.162N         P=0.109N         P=0.135N         P=0.162N                         | 
|LOGISTIC REGRESSION|        P=0.040N*        P=0.134N         P=0.116N         P=0.148N         P=0.155N                         | 
|COCH-ARM / FISHERS |        P=0.042N*        P=0.125N         P=0.121N         P=0.167N         P=0.156N                         | 
|ORDER RESTRICTED   |        P=0.009N**       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 53      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/50 (10%)       3/50 (6%)        7/50 (14%)       5/37 (14%)       2/32 (6%)                        | 
|POLY-3 RATE (b)    |        5/34.44          3/32.15          7/32.61          5/22.33          2/20.67                          | 
|POLY-3 PERCENT (g) |        14.5%            9.3%             21.5%            22.4%            9.7%                             | 
|TERMINAL (d)       |        2/19 (11%)       1/21 (5%)        1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        475              322              147              501              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.445          P=0.372N         P=0.263          P=0.256          P=0.501N                         | 
|POLY 3             |        P=0.513          P=0.392N         P=0.335          P=0.344          P=0.459N                         | 
|POLY 1.5           |        P=0.519          P=0.389N         P=0.355          P=0.372          P=0.456N                         | 
|POLY 6             |        P=0.495          P=0.388N         P=0.309          P=0.318          P=0.467N                         | 
|LOGISTIC REGRESSION|        P=0.532N         P=0.357N         P=0.385          P=0.358          P=0.428N                         | 
|COCH-ARM / FISHERS |        P=0.534N         P=0.357N         P=0.380          P=0.429          P=0.436N                         | 
|ORDER RESTRICTED   |        P=0.460N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       6/49 (12%)       6/50 (12%)       2/40 (5%)        8/42 (19%)                       | 
|POLY-3 RATE (b)    |        7/37.57          6/33.99          6/37.25          2/32.44          8/32.68                          | 
|POLY-3 PERCENT (g) |        18.6%            17.7%            16.1%            6.2%             24.5%                            | 
|TERMINAL (d)       |        2/20 (10%)       1/18 (6%)        3/24 (13%)       1/20 (5%)        3/19 (16%)                       | 
|FIRST INCIDENCE    |        372              207              585              539              49                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.491          P=0.606N         P=0.415N         P=0.107N         P=0.385                          | 
|POLY 3             |        P=0.481          P=0.579N         P=0.507N         P=0.113N         P=0.379                          | 
|POLY 1.5           |        P=0.462          P=0.543N         P=0.505N         P=0.117N         P=0.377                          | 
|POLY 6             |        P=0.492          P=0.616N         P=0.495N         P=0.111N         P=0.381                          | 
|LOGISTIC REGRESSION|        P=0.390          P=0.501N         P=0.489N         P=0.165N         P=0.375                          | 
|COCH-ARM / FISHERS |        P=0.405          P=0.516N         P=0.500N         P=0.144N         P=0.355                          | 
|ORDER RESTRICTED   |        P=0.233          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 54      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)        1/37 (3%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        1/33.13          0/30.37          0/29.15          1/21.09          1/19.54                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             0.0%             4.7%             5.1%                             | 
|TERMINAL (d)       |        1/19 (5%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          ---              ---              631              563                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.206          P=0.480N         P=0.576N         P=0.557          P=0.602                          | 
|POLY 3             |        P=0.259          P=0.517N         P=0.526N         P=0.656          P=0.639                          | 
|POLY 1.5           |        P=0.256          P=0.516N         P=0.515N         P=0.668          P=0.640                          | 
|POLY 6             |        P=0.260          P=0.514N         P=0.539N         P=0.640          P=0.638                          | 
|LOGISTIC REGRESSION|        P=0.233          (e)              (e)              P=0.622          P=0.637                          | 
|COCH-ARM / FISHERS |        P=0.256          P=0.500N         P=0.500N         P=0.673          P=0.631                          | 
|ORDER RESTRICTED   |        P=0.326          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/49 (2%)        3/50 (6%)        4/40 (10%)       1/42 (2%)                        | 
|POLY-3 RATE (b)    |        1/34.96          1/31.54          3/37.40          4/32.19          1/28.81                          | 
|POLY-3 PERCENT (g) |        2.9%             3.2%             8.0%             12.4%            3.5%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        1/24 (4%)        3/20 (15%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        668 (T)          500              460              614              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.348          P=0.736          P=0.361          P=0.180          P=0.752                          | 
|POLY 3             |        P=0.294          P=0.738          P=0.329          P=0.150          P=0.718                          | 
|POLY 1.5           |        P=0.286          P=0.748          P=0.319          P=0.142          P=0.718                          | 
|POLY 6             |        P=0.303          P=0.728          P=0.346          P=0.157          P=0.718                          | 
|LOGISTIC REGRESSION|        P=0.307          P=0.751          P=0.315          P=0.163          P=0.752                          | 
|COCH-ARM / FISHERS |        P=0.286          P=0.747          P=0.309          P=0.119          P=0.707                          | 
|ORDER RESTRICTED   |        P=0.334          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 55      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/50 (24%)      16/50 (32%)      13/50 (26%)      16/37 (43%)      14/32 (44%)                      | 
|POLY-3 RATE (b)    |        12/36.08         16/35.72         13/32.37         16/25.52         14/22.06                         | 
|POLY-3 PERCENT (g) |        33.3%            44.8%            40.2%            62.7%            63.5%                            | 
|TERMINAL (d)       |        3/19 (16%)       6/21 (29%)       6/13 (46%)       4/7 (57%)        4/8 (50%)                        | 
|FIRST INCIDENCE    |        446              322              376              341              376                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       P=0.258          P=0.245          P=0.008 **       P=0.024 *                        | 
|POLY 3             |        P=0.003 **       P=0.219          P=0.364          P=0.016 *        P=0.018 *                        | 
|POLY 1.5           |        P=0.005 **       P=0.206          P=0.417          P=0.021 *        P=0.022 *                        | 
|POLY 6             |        P=0.002 **       P=0.251          P=0.294          P=0.013 *        P=0.017 *                        | 
|LOGISTIC REGRESSION|        P=0.006 **       P=0.198          P=0.389          P=0.018 *        P=0.023 *                        | 
|COCH-ARM / FISHERS |        P=0.016 *        P=0.252          P=0.500          P=0.048 *        P=0.052                          | 
|ORDER RESTRICTED   |        P=0.020 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/50 (24%)      11/49 (22%)      21/50 (42%)      12/40 (30%)      10/42 (24%)                      | 
|POLY-3 RATE (b)    |        12/37.09         11/35.32         21/43.08         12/33.52         10/30.37                         | 
|POLY-3 PERCENT (g) |        32.4%            31.1%            48.8%            35.8%            32.9%                            | 
|TERMINAL (d)       |        4/20 (20%)       2/18 (11%)       9/24 (38%)       7/20 (35%)       7/19 (37%)                       | 
|FIRST INCIDENCE    |        497              369              181              539              412                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.387N         P=0.494          P=0.129          P=0.540          P=0.548N                         | 
|POLY 3             |        P=0.519N         P=0.557N         P=0.099          P=0.478          P=0.585                          | 
|POLY 1.5           |        P=0.530N         P=0.530N         P=0.076          P=0.450          P=0.592                          | 
|POLY 6             |        P=0.532N         P=0.588N         P=0.130          P=0.490          P=0.565                          | 
|LOGISTIC REGRESSION|        P=0.520N         P=0.562N         P=0.046 *        P=0.480          P=0.588                          | 
|COCH-ARM / FISHERS |        P=0.508          P=0.522N         P=0.044 *        P=0.344          P=0.590N                         | 
|ORDER RESTRICTED   |        P=0.419          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 56      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          0/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/49 (0%)        0/50 (0%)        1/40 (3%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        2/35.32          0/30.96          0/36.65          1/31.97          1/28.81                          | 
|POLY-3 PERCENT (g) |        5.7%             0.0%             0.0%             3.1%             3.5%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        577              ---              ---              668 (T)          668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.577N         P=0.295N         P=0.220N         P=0.527N         P=0.543N                         | 
|POLY 3             |        P=0.604          P=0.266N         P=0.228N         P=0.535N         P=0.571N                         | 
|POLY 1.5           |        P=0.589          P=0.253N         P=0.232N         P=0.544N         P=0.568N                         | 
|POLY 6             |        P=0.599N         P=0.283N         P=0.222N         P=0.530N         P=0.575N                         | 
|LOGISTIC REGRESSION|        P=0.595          P=0.265N         P=0.228N         P=0.529N         P=0.568N                         | 
|COCH-ARM / FISHERS |        P=0.567          P=0.253N         P=0.247N         P=0.584N         P=0.566N                         | 
|ORDER RESTRICTED   |        P=0.257N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 57      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        5/50 (10%)       2/37 (5%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        2/33.19          1/30.37          5/31.01          2/22.71          1/19.26                          | 
|POLY-3 PERCENT (g) |        6.0%             3.3%             16.1%            8.8%             5.2%                             | 
|TERMINAL (d)       |        1/19 (5%)        1/21 (5%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        654              668 (T)          474              298              640                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.421          P=0.477N         P=0.135          P=0.439          P=0.713                          | 
|POLY 3             |        P=0.496          P=0.531N         P=0.183          P=0.552          P=0.685N                         | 
|POLY 1.5           |        P=0.507          P=0.528N         P=0.194          P=0.562          P=0.680N                         | 
|POLY 6             |        P=0.474          P=0.526N         P=0.174          P=0.534          P=0.691N                         | 
|LOGISTIC REGRESSION|        P=0.521          P=0.506N         P=0.180          P=0.610          P=0.709N                         | 
|COCH-ARM / FISHERS |        P=0.537          P=0.500N         P=0.218          P=0.571          P=0.779                          | 
|ORDER RESTRICTED   |        P=0.403          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/49 (0%)        0/50 (0%)        2/40 (5%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        1/35.01          0/30.96          0/36.65          2/33.37          2/29.44                          | 
|POLY-3 PERCENT (g) |        2.9%             0.0%             0.0%             6.0%             6.8%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        658              ---              ---              359              479                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.085          P=0.531N         P=0.465N         P=0.488          P=0.460                          | 
|POLY 3             |        P=0.084          P=0.525N         P=0.491N         P=0.483          P=0.439                          | 
|POLY 1.5           |        P=0.078          P=0.514N         P=0.495N         P=0.467          P=0.437                          | 
|POLY 6             |        P=0.090          P=0.537N         P=0.484N         P=0.497          P=0.442                          | 
|LOGISTIC REGRESSION|        P=0.071          P=0.540N         P=0.474N         P=0.320          P=0.434                          | 
|COCH-ARM / FISHERS |        P=0.072          P=0.505N         P=0.500N         P=0.416          P=0.434                          | 
|ORDER RESTRICTED   |        P=0.147          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 58      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       3/50 (6%)        0/50 (0%)        1/37 (3%)        4/32 (13%)                       | 
|POLY-3 RATE (b)    |        6/34.31          3/31.86          0/29.15          1/21.41          4/19.78                          | 
|POLY-3 PERCENT (g) |        17.5%            9.4%             0.0%             4.7%             20.2%                            | 
|TERMINAL (d)       |        2/19 (11%)       1/21 (5%)        0/13 (0%)        0/7 (0%)         2/8 (25%)                        | 
|FIRST INCIDENCE    |        538              418              ---              539              488                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.402          P=0.260N         P=0.043N*        P=0.236N         P=0.452                          | 
|POLY 3             |        P=0.538          P=0.274N         P=0.024N*        P=0.164N         P=0.545                          | 
|POLY 1.5           |        P=0.555          P=0.273N         P=0.020N*        P=0.146N         P=0.557                          | 
|POLY 6             |        P=0.508          P=0.268N         P=0.031N*        P=0.192N         P=0.525                          | 
|LOGISTIC REGRESSION|        P=0.533          P=0.268N         P=0.025N*        P=0.154N         P=0.548                          | 
|COCH-ARM / FISHERS |        P=0.537N         P=0.243N         P=0.013N*        P=0.118N         P=0.602                          | 
|ORDER RESTRICTED   |        P=0.163          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        2/49 (4%)        10/50 (20%)      3/40 (8%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        2/35.32          2/30.96          10/37.79         3/32.09          2/29.68                          | 
|POLY-3 PERCENT (g) |        5.7%             6.5%             26.5%            9.4%             6.7%                             | 
|TERMINAL (d)       |        1/20 (5%)        2/18 (11%)       8/24 (33%)       2/20 (10%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        577              668 (T)          181              641              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.434N         P=0.631          P=0.029 *        P=0.479          P=0.644                          | 
|POLY 3             |        P=0.462N         P=0.647          P=0.016 *        P=0.456          P=0.632                          | 
|POLY 1.5           |        P=0.495N         P=0.669          P=0.015 *        P=0.443          P=0.630                          | 
|POLY 6             |        P=0.434N         P=0.621          P=0.018 *        P=0.464          P=0.632                          | 
|LOGISTIC REGRESSION|        P=0.506N         P=0.628          P=0.017 *        P=0.467          P=0.631                          | 
|COCH-ARM / FISHERS |        P=0.539N         P=0.684          P=0.014 *        P=0.394          P=0.623                          | 
|ORDER RESTRICTED   |        P=0.194          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 59      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node                                                                                                                       | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/12 (25%)       2/10 (20%)       1/15 (7%)        0/6 (0%)         0/2 (0%)                         | 
|POLY-3 RATE (b)    |        3/6.80           2/6.23           1/9.95           0/2.81           0/0.97                           | 
|POLY-3 PERCENT (g) |        44.1%            32.1%            10.1%            0.0%             0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         0/3 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        308              322              243              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.051N         P=0.558N         P=0.335N         P=0.206N         P=0.237N                         | 
|POLY 3             |        P=0.067N         P=0.551N         P=0.148N         P=0.283N         P=0.603N                         | 
|POLY 1.5           |        P=0.073N         P=0.540N         P=0.168N         P=0.262N         P=0.576N                         | 
|POLY 6             |        P=0.060N         P=0.619N         P=0.140N         P=0.314N         P=0.637N                         | 
|LOGISTIC REGRESSION|        P=0.099N         P=0.651          P=0.327N         P=0.284N         P=0.601N                         | 
|COCH-ARM / FISHERS |        P=0.075N         P=0.594N         P=0.216N         P=0.270N         P=0.604N                         | 
|ORDER RESTRICTED   |        P=0.560N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node                                                                                                                       | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/14 (7%)        1/23 (4%)        2/16 (13%)       0/12 (0%)        0/16 (0%)                        | 
|POLY-3 RATE (b)    |        1/6.20           1/12.90          2/10.85          0/9.59           0/11.87                          | 
|POLY-3 PERCENT (g) |        16.1%            7.8%             18.4%            0.0%             0.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         1/4 (25%)        0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        460              475              654              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.098N         P=0.749          P=0.734N         P=0.510N         P=0.538N                         | 
|POLY 3             |        P=0.097N         P=0.590N         P=0.694          P=0.416N         P=0.376N                         | 
|POLY 1.5           |        P=0.123N         P=0.610N         P=0.637          P=0.459N         P=0.411N                         | 
|POLY 6             |        P=0.070N         P=0.567N         P=0.710N         P=0.364N         P=0.337N                         | 
|LOGISTIC REGRESSION|        P=0.133N         P=0.673N         P=0.762N         P=0.644N         P=0.576N                         | 
|COCH-ARM / FISHERS |        P=0.178N         P=0.620N         P=0.552          P=0.538N         P=0.467N                         | 
|ORDER RESTRICTED   |        P=0.256N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 60      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node                                                                                                                       | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/12 (25%)       0/10 (0%)        0/15 (0%)        0/6 (0%)         2/2 (100%)                       | 
|POLY-3 RATE (b)    |        3/6.80           0/4.46           0/9.00           0/2.81           2/2.00                           | 
|POLY-3 PERCENT (g) |        44.1%            0.0%             0.0%             0.0%             100.0%                           | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         0/3 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        308              ---              ---              ---              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.474          P=0.148N         P=0.140N         P=0.206N         P=0.609                          | 
|POLY 3             |        P=0.040 *        P=0.161N         P=0.045N*        P=0.283N         P=0.213                          | 
|POLY 1.5           |        P=0.054          P=0.134N         P=0.051N         P=0.262N         P=0.142                          | 
|POLY 6             |        P=0.045 *        P=0.238N         P=0.042N*        P=0.314N         P=0.317                          | 
|LOGISTIC REGRESSION|        P=0.191          P=0.192N         P=0.112N         P=0.284N         P=0.092                          | 
|COCH-ARM / FISHERS |        P=0.219          P=0.143N         P=0.075N         P=0.270N         P=0.110                          | 
|ORDER RESTRICTED   |        P=0.028 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node                                                                                                                       | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/14 (14%)       0/23 (0%)        0/16 (0%)        0/12 (0%)        1/16 (6%)                        | 
|POLY-3 RATE (b)    |        2/6.48           0/12.26          0/10.79          0/9.59           1/12.56                          | 
|POLY-3 PERCENT (g) |        30.9%            0.0%             0.0%             0.0%             8.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         0/4 (0%)         0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        460              ---              ---              ---              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.444N         P=0.274N         P=0.214N         P=0.250N         P=0.557N                         | 
|POLY 3             |        P=0.493N         P=0.095N         P=0.123N         P=0.145N         P=0.277N                         | 
|POLY 1.5           |        P=0.481N         P=0.105N         P=0.149N         P=0.185N         P=0.337N                         | 
|POLY 6             |        P=0.506N         P=0.088N         P=0.097N         P=0.109N         P=0.220N                         | 
|LOGISTIC REGRESSION|        P=0.527N         P=0.103N         P=0.163N         P=0.220N         P=0.510N                         | 
|COCH-ARM / FISHERS |        P=0.459N         P=0.137N         P=0.209N         P=0.280N         P=0.448N                         | 
|ORDER RESTRICTED   |        P=0.018N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 61      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node                                                                                                                       | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/12 (8%)        3/10 (30%)       2/15 (13%)       2/6 (33%)        0/2 (0%)                         | 
|POLY-3 RATE (b)    |        1/5.02           3/6.89           2/10.84          2/4.57           0/0.97                           | 
|POLY-3 PERCENT (g) |        19.9%            43.6%            18.5%            43.8%            0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         0/3 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        453              322              243              329              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.396N         P=0.269          P=0.479          P=0.357          P=0.600N                         | 
|POLY 3             |        P=0.612          P=0.409          P=0.710N         P=0.460          P=0.844N                         | 
|POLY 1.5           |        P=0.558          P=0.344          P=0.695          P=0.373          P=0.841N                         | 
|POLY 6             |        P=0.656          P=0.445          P=0.675N         P=0.532          P=0.851N                         | 
|LOGISTIC REGRESSION|        P=0.364          P=0.152          P=0.460          P=0.203          P=0.850N                         | 
|COCH-ARM / FISHERS |        P=0.451          P=0.226          P=0.586          P=0.245          P=0.857N                         | 
|ORDER RESTRICTED   |        P=0.644N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node                                                                                                                       | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/14 (7%)        3/23 (13%)       0/16 (0%)        1/12 (8%)        0/16 (0%)                        | 
|POLY-3 RATE (b)    |        1/6.11           3/14.27          0/10.79          1/10.20          0/11.87                          | 
|POLY-3 PERCENT (g) |        16.4%            21.0%            0.0%             9.8%             0.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         0/4 (0%)         0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        497              219              ---              488              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.183N         P=0.263          P=0.505N         P=0.749          P=0.559N                         | 
|POLY 3             |        P=0.108N         P=0.634          P=0.390N         P=0.637N         P=0.374N                         | 
|POLY 1.5           |        P=0.128N         P=0.583          P=0.422N         P=0.704N         P=0.409N                         | 
|POLY 6             |        P=0.089N         P=0.697          P=0.352N         P=0.551N         P=0.335N                         | 
|LOGISTIC REGRESSION|        P=0.317N         P=0.422          P=0.485N         P=0.710          P=0.517N                         | 
|COCH-ARM / FISHERS |        P=0.176N         P=0.509          P=0.467N         P=0.720          P=0.467N                         | 
|ORDER RESTRICTED   |        P=0.215N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 62      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        1/49 (2%)        3/37 (8%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          1/29.14          3/23.31          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             3.4%             12.9%            0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/12 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              147              157              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.156          (e)              P=0.508          P=0.072          (e)                              | 
|POLY 3             |        P=0.128          (e)              P=0.474          P=0.061          (e)                              | 
|POLY 1.5           |        P=0.133          (e)              P=0.484          P=0.064          (e)                              | 
|POLY 6             |        P=0.121          (e)              P=0.461          P=0.057          (e)                              | 
|LOGISTIC REGRESSION|        P=0.228          (e)              P=0.371          P=0.104          (e)                              | 
|COCH-ARM / FISHERS |        P=0.157          (e)              P=0.495          P=0.073          (e)                              | 
|ORDER RESTRICTED   |        P=0.144          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/49 (4%)        2/47 (4%)        1/49 (2%)        0/40 (0%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        2/35.09          2/30.36          1/36.48          0/31.97          4/30.87                          | 
|POLY-3 PERCENT (g) |        5.7%             6.6%             2.7%             0.0%             13.0%                            | 
|TERMINAL (d)       |        0/20 (0%)        0/17 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        443              536              490              ---              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.229          P=0.611          P=0.496N         P=0.270N         P=0.263                          | 
|POLY 3             |        P=0.253          P=0.642          P=0.486N         P=0.256N         P=0.276                          | 
|POLY 1.5           |        P=0.245          P=0.661          P=0.492N         P=0.261N         P=0.272                          | 
|POLY 6             |        P=0.255          P=0.622          P=0.476N         P=0.255N         P=0.281                          | 
|LOGISTIC REGRESSION|        P=0.209          P=0.686          P=0.512N         P=0.333N         P=0.277                          | 
|COCH-ARM / FISHERS |        P=0.216          P=0.676          P=0.500N         P=0.300N         P=0.268                          | 
|ORDER RESTRICTED   |        P=0.075          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 63      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        1/49 (2%)        1/37 (3%)        2/32 (6%)                        | 
|POLY-3 RATE (b)    |        2/34.92          0/30.37          1/28.76          1/21.09          2/20.90                          | 
|POLY-3 PERCENT (g) |        5.7%             0.0%             3.5%             4.7%             9.6%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/12 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        308              ---              490              631              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.224          P=0.267N         P=0.524N         P=0.675N         P=0.499                          | 
|POLY 3             |        P=0.232          P=0.268N         P=0.568N         P=0.670N         P=0.499                          | 
|POLY 1.5           |        P=0.233          P=0.263N         P=0.545N         P=0.648N         P=0.501                          | 
|POLY 6             |        P=0.225          P=0.268N         P=0.594N         P=0.694N         P=0.496                          | 
|LOGISTIC REGRESSION|        P=0.277          P=0.153N         P=0.452N         P=0.548N         P=0.695                          | 
|COCH-ARM / FISHERS |        P=0.233          P=0.247N         P=0.508N         P=0.613N         P=0.510                          | 
|ORDER RESTRICTED   |        P=0.232          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/49 (4%)        1/47 (2%)        0/49 (0%)        3/40 (8%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        2/34.50          1/30.07          0/35.88          3/32.00          2/30.15                          | 
|POLY-3 PERCENT (g) |        5.8%             3.3%             0.0%             9.4%             6.6%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/17 (0%)        0/24 (0%)        2/20 (10%)       0/19 (0%)                        | 
|FIRST INCIDENCE    |        577              475              ---              662              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.266          P=0.568N         P=0.221N         P=0.488          P=0.632                          | 
|POLY 3             |        P=0.252          P=0.548N         P=0.227N         P=0.465          P=0.647                          | 
|POLY 1.5           |        P=0.242          P=0.530N         P=0.231N         P=0.453          P=0.641                          | 
|POLY 6             |        P=0.261          P=0.569N         P=0.221N         P=0.471          P=0.652                          | 
|LOGISTIC REGRESSION|        P=0.232          P=0.520N         P=0.229N         P=0.480          P=0.642                          | 
|COCH-ARM / FISHERS |        P=0.230          P=0.516N         P=0.247N         P=0.404          P=0.631                          | 
|ORDER RESTRICTED   |        P=0.302          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 64      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       0/50 (0%)        6/49 (12%)       4/37 (11%)       5/32 (16%)                       | 
|POLY-3 RATE (b)    |        7/36.88          0/30.37          6/31.19          4/23.16          5/21.09                          | 
|POLY-3 PERCENT (g) |        19.0%            0.0%             19.2%            17.3%            23.7%                            | 
|TERMINAL (d)       |        1/19 (5%)        0/21 (0%)        1/12 (8%)        0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        308              ---              229              298              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.136          P=0.015N*        P=0.587          P=0.582N         P=0.451                          | 
|POLY 3             |        P=0.178          P=0.015N*        P=0.611          P=0.569N         P=0.464                          | 
|POLY 1.5           |        P=0.185          P=0.012N*        P=0.582N         P=0.527N         P=0.481                          | 
|POLY 6             |        P=0.162          P=0.016N*        P=0.547          P=0.623N         P=0.444                          | 
|LOGISTIC REGRESSION|        P=0.214          P=0.007N**       P=0.458N         P=0.390N         P=0.578                          | 
|COCH-ARM / FISHERS |        P=0.195          P=0.006N**       P=0.516N         P=0.459N         P=0.540                          | 
|ORDER RESTRICTED   |        P=0.162          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/49 (14%)       3/47 (6%)        2/49 (4%)        4/40 (10%)       6/42 (14%)                       | 
|POLY-3 RATE (b)    |        7/36.00          3/31.46          2/35.94          4/32.49          6/30.97                          | 
|POLY-3 PERCENT (g) |        19.4%            9.5%             5.6%             12.3%            19.4%                            | 
|TERMINAL (d)       |        3/20 (15%)       0/17 (0%)        1/24 (4%)        3/20 (15%)       3/19 (16%)                       | 
|FIRST INCIDENCE    |        460              207              654              523              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.402          P=0.249N         P=0.064N         P=0.297N         P=0.605N                         | 
|POLY 3             |        P=0.394          P=0.211N         P=0.075N         P=0.317N         P=0.619N                         | 
|POLY 1.5           |        P=0.372          P=0.187N         P=0.076N         P=0.328N         P=0.619N                         | 
|POLY 6             |        P=0.408          P=0.242N         P=0.072N         P=0.317N         P=0.622                          | 
|LOGISTIC REGRESSION|        P=0.336          P=0.170N         P=0.074N         P=0.340N         P=0.615                          | 
|COCH-ARM / FISHERS |        P=0.336          P=0.176N         P=0.080N         P=0.391N         P=0.616                          | 
|ORDER RESTRICTED   |        P=0.286N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 65      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        3/49 (6%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          3/30.02          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             10.0%            0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        1/12 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              187              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.588N         (e)              P=0.093          (e)              (e)                              | 
|POLY 3             |        P=0.589N         (e)              P=0.099          (e)              (e)                              | 
|POLY 1.5           |        P=0.568N         (e)              P=0.106          (e)              (e)                              | 
|POLY 6             |        P=0.619N         (e)              P=0.090          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.490N         (e)              P=0.139          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.532N         (e)              P=0.117          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.297          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/49 (6%)        4/47 (9%)        5/49 (10%)       5/40 (13%)       7/42 (17%)                       | 
|POLY-3 RATE (b)    |        3/34.07          4/30.41          5/37.31          5/32.32          7/30.42                          | 
|POLY-3 PERCENT (g) |        8.8%             13.2%            13.4%            15.5%            23.0%                            | 
|TERMINAL (d)       |        3/20 (15%)       2/17 (12%)       0/24 (0%)        2/20 (10%)       4/19 (21%)                       | 
|FIRST INCIDENCE    |        668 (T)          500              460              608              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.083          P=0.399          P=0.446          P=0.361          P=0.124                          | 
|POLY 3             |        P=0.071          P=0.437          P=0.406          P=0.323          P=0.106                          | 
|POLY 1.5           |        P=0.063          P=0.459          P=0.384          P=0.304          P=0.102                          | 
|POLY 6             |        P=0.078          P=0.417          P=0.442          P=0.341          P=0.111                          | 
|LOGISTIC REGRESSION|        P=0.059          P=0.404          P=0.375          P=0.344          P=0.097                          | 
|COCH-ARM / FISHERS |        P=0.051          P=0.476          P=0.357          P=0.250          P=0.103                          | 
|ORDER RESTRICTED   |        P=0.084          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 66      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/50 (22%)      9/50 (18%)       6/49 (12%)       3/37 (8%)        4/32 (13%)                       | 
|POLY-3 RATE (b)    |        11/40.21         9/34.75          6/31.16          3/22.91          4/22.76                          | 
|POLY-3 PERCENT (g) |        27.4%            25.9%            19.3%            13.1%            17.6%                            | 
|TERMINAL (d)       |        0/19 (0%)        3/21 (14%)       0/12 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        308              147              229              298              192                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.133N         P=0.476N         P=0.242N         P=0.138N         P=0.276N                         | 
|POLY 3             |        P=0.111N         P=0.548N         P=0.303N         P=0.165N         P=0.287N                         | 
|POLY 1.5           |        P=0.091N         P=0.508N         P=0.236N         P=0.123N         P=0.263N                         | 
|POLY 6             |        P=0.149N         P=0.576N         P=0.390N         P=0.229N         P=0.327N                         | 
|LOGISTIC REGRESSION|        P=0.041N*        P=0.300N         P=0.102N         P=0.034N*        P=0.093N                         | 
|COCH-ARM / FISHERS |        P=0.070N         P=0.402N         P=0.154N         P=0.071N         P=0.216N                         | 
|ORDER RESTRICTED   |        P=0.244N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/49 (10%)       0/47 (0%)        0/49 (0%)        0/40 (0%)        3/42 (7%)                        | 
|POLY-3 RATE (b)    |        5/35.69          0/29.43          0/35.88          0/31.97          3/30.15                          | 
|POLY-3 PERCENT (g) |        14.0%            0.0%             0.0%             0.0%             10.0%                            | 
|TERMINAL (d)       |        1/20 (5%)        0/17 (0%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        460              ---              ---              ---              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.423N         P=0.053N         P=0.029N*        P=0.040N*        P=0.445N                         | 
|POLY 3             |        P=0.386N         P=0.048N*        P=0.029N*        P=0.038N*        P=0.451N                         | 
|POLY 1.5           |        P=0.412N         P=0.040N*        P=0.029N*        P=0.040N*        P=0.450N                         | 
|POLY 6             |        P=0.365N         P=0.059N         P=0.027N*        P=0.038N*        P=0.455N                         | 
|LOGISTIC REGRESSION|        P=0.461N         P=0.038N*        P=0.033N*        P=0.052N         P=0.443N                         | 
|COCH-ARM / FISHERS |        P=0.458N         P=0.031N*        P=0.028N*        P=0.046N*        P=0.447N                         | 
|ORDER RESTRICTED   |        P=0.018N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 67      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/50 (22%)      7/50 (14%)       9/49 (18%)       6/37 (16%)       9/32 (28%)                       | 
|POLY-3 RATE (b)    |        11/36.87         7/32.62          9/31.66          6/24.31          9/22.72                          | 
|POLY-3 PERCENT (g) |        29.8%            21.5%            28.4%            24.7%            39.6%                            | 
|TERMINAL (d)       |        4/19 (21%)       4/21 (19%)       4/12 (33%)       1/7 (14%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        111              322              243              167              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.096          P=0.233N         P=0.523          P=0.574          P=0.223                          | 
|POLY 3             |        P=0.220          P=0.299N         P=0.556N         P=0.441N         P=0.308                          | 
|POLY 1.5           |        P=0.223          P=0.289N         P=0.504N         P=0.408N         P=0.298                          | 
|POLY 6             |        P=0.211          P=0.294N         P=0.590          P=0.489N         P=0.325                          | 
|LOGISTIC REGRESSION|        P=0.251          P=0.223N         P=0.408N         P=0.298N         P=0.359                          | 
|COCH-ARM / FISHERS |        P=0.250          P=0.218N         P=0.421N         P=0.348N         P=0.354                          | 
|ORDER RESTRICTED   |        P=0.226          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/49 (18%)       10/47 (21%)      17/49 (35%)      10/40 (25%)      4/42 (10%)                       | 
|POLY-3 RATE (b)    |        9/36.43          10/33.94         17/38.21         10/33.69         4/30.17                          | 
|POLY-3 PERCENT (g) |        24.7%            29.5%            44.5%            29.7%            13.3%                            | 
|TERMINAL (d)       |        5/20 (25%)       2/17 (12%)       11/24 (46%)      7/20 (35%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        179              207              425              488              455                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.100N         P=0.392          P=0.125          P=0.460          P=0.187N                         | 
|POLY 3             |        P=0.127N         P=0.427          P=0.055          P=0.420          P=0.192N                         | 
|POLY 1.5           |        P=0.146N         P=0.449          P=0.049 *        P=0.386          P=0.196N                         | 
|POLY 6             |        P=0.107N         P=0.409          P=0.072          P=0.452          P=0.183N                         | 
|LOGISTIC REGRESSION|        P=0.141N         P=0.477          P=0.061          P=0.322          P=0.184N                         | 
|COCH-ARM / FISHERS |        P=0.152N         P=0.459          P=0.054          P=0.308          P=0.184N                         | 
|ORDER RESTRICTED   |        P=0.054N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 68      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Infiltration Cellular Plasma Cell                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/49 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          0/28.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/12 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Infiltration Cellular Plasma Cell                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/49 (4%)        0/47 (0%)        0/49 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        2/34.14          0/29.43          0/35.88          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        5.9%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/17 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        651              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.083N         P=0.274N         P=0.202N         P=0.240N         P=0.262N                         | 
|POLY 3             |        P=0.088N         P=0.270N         P=0.225N         P=0.250N         P=0.275N                         | 
|POLY 1.5           |        P=0.092N         P=0.257N         P=0.230N         P=0.258N         P=0.275N                         | 
|POLY 6             |        P=0.085N         P=0.286N         P=0.217N         P=0.245N         P=0.275N                         | 
|LOGISTIC REGRESSION|        P=0.082N         P=0.286N         P=0.203N         P=0.236N         P=0.267N                         | 
|COCH-ARM / FISHERS |        P=0.096N         P=0.258N         P=0.247N         P=0.300N         P=0.287N                         | 
|ORDER RESTRICTED   |        P=0.026N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 69      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        1/49 (2%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          1/30.37          1/28.53          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             3.3%             3.5%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        0/12 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              668 (T)          570              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.504N         P=0.520          P=0.469          (e)              (e)                              | 
|POLY 3             |        P=0.481N         P=0.483          P=0.470          (e)              (e)                              | 
|POLY 1.5           |        P=0.465N         P=0.484          P=0.480          (e)              (e)                              | 
|POLY 6             |        P=0.502N         P=0.486          P=0.458          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.457N         P=0.520          P=0.484          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.434N         P=0.500          P=0.495          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.492N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/49 (10%)       4/47 (9%)        2/49 (4%)        4/40 (10%)       6/42 (14%)                       | 
|POLY-3 RATE (b)    |        5/34.72          4/30.01          2/35.94          4/32.31          6/28.81                          | 
|POLY-3 PERCENT (g) |        14.4%            13.3%            5.6%             12.4%            20.8%                            | 
|TERMINAL (d)       |        3/20 (15%)       1/17 (6%)        1/24 (4%)        2/20 (10%)       6/19 (32%)                       | 
|FIRST INCIDENCE    |        573              559              654              608              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.284          P=0.626N         P=0.165N         P=0.523N         P=0.432                          | 
|POLY 3             |        P=0.243          P=0.593N         P=0.198N         P=0.546N         P=0.366                          | 
|POLY 1.5           |        P=0.232          P=0.558N         P=0.205N         P=0.564N         P=0.375                          | 
|POLY 6             |        P=0.247          P=0.631N         P=0.187N         P=0.535N         P=0.352                          | 
|LOGISTIC REGRESSION|        P=0.257          P=0.617N         P=0.183N         P=0.533N         P=0.384                          | 
|COCH-ARM / FISHERS |        P=0.211          P=0.527N         P=0.218N         P=0.646          P=0.391                          | 
|ORDER RESTRICTED   |        P=0.208          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 70      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/49 (0%)        2/49 (4%)        3/36 (8%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        1/33.27          0/30.28          2/30.60          3/22.31          0/19.14                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             6.5%             13.5%            0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        635              ---              147              157              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.354          P=0.509N         P=0.456          P=0.158          P=0.614N                         | 
|POLY 3             |        P=0.332          P=0.519N         P=0.471          P=0.172          P=0.609N                         | 
|POLY 1.5           |        P=0.341          P=0.518N         P=0.481          P=0.181          P=0.605N                         | 
|POLY 6             |        P=0.316          P=0.516N         P=0.455          P=0.159          P=0.614N                         | 
|LOGISTIC REGRESSION|        P=0.447          P=0.515N         P=0.531          P=0.253          P=0.614N                         | 
|COCH-ARM / FISHERS |        P=0.374          P=0.505N         P=0.492          P=0.196          P=0.610N                         | 
|ORDER RESTRICTED   |        P=0.327          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        4/48 (8%)        2/46 (4%)        1/40 (3%)        5/42 (12%)                       | 
|POLY-3 RATE (b)    |        2/35.99          4/32.87          2/35.54          1/32.56          5/31.91                          | 
|POLY-3 PERCENT (g) |        5.6%             12.2%            5.6%             3.1%             15.7%                            | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/22 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        443              417              328              497              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.206          P=0.266          P=0.687N         P=0.537N         P=0.157                          | 
|POLY 3             |        P=0.229          P=0.293          P=0.691          P=0.535N         P=0.165                          | 
|POLY 1.5           |        P=0.219          P=0.307          P=0.681          P=0.544N         P=0.159                          | 
|POLY 6             |        P=0.234          P=0.281          P=0.688N         P=0.530N         P=0.171                          | 
|LOGISTIC REGRESSION|        P=0.182          P=0.325          P=0.642          P=0.680N         P=0.165                          | 
|COCH-ARM / FISHERS |        P=0.190          P=0.319          P=0.659          P=0.584N         P=0.152                          | 
|ORDER RESTRICTED   |        P=0.101          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 71      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        7/49 (14%)       3/49 (6%)        6/36 (17%)       2/32 (6%)                        | 
|POLY-3 RATE (b)    |        2/33.83          7/31.16          3/31.13          6/22.60          2/19.93                          | 
|POLY-3 PERCENT (g) |        5.9%             22.5%            9.6%             26.6%            10.0%                            | 
|TERMINAL (d)       |        1/19 (5%)        6/21 (29%)       0/13 (0%)        0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        446              329              229              329              488                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.200          P=0.088          P=0.426          P=0.025 *        P=0.476                          | 
|POLY 3             |        P=0.288          P=0.055          P=0.462          P=0.034 *        P=0.493                          | 
|POLY 1.5           |        P=0.296          P=0.057          P=0.475          P=0.038 *        P=0.495                          | 
|POLY 6             |        P=0.282          P=0.056          P=0.440          P=0.029 *        P=0.492                          | 
|LOGISTIC REGRESSION|        P=0.342          P=0.062          P=0.535          P=0.052          P=0.513                          | 
|COCH-ARM / FISHERS |        P=0.353          P=0.075          P=0.490          P=0.053          P=0.510                          | 
|ORDER RESTRICTED   |        P=0.185          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        3/48 (6%)        2/46 (4%)        3/40 (8%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        2/35.30          3/30.60          2/34.41          3/31.97          1/28.81                          | 
|POLY-3 PERCENT (g) |        5.7%             9.8%             5.8%             9.4%             3.5%                             | 
|TERMINAL (d)       |        0/20 (0%)        3/18 (17%)       0/22 (0%)        3/20 (15%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        612              668 (T)          621              668 (T)          668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.374N         P=0.435          P=0.621N         P=0.496          P=0.547N                         | 
|POLY 3             |        P=0.453N         P=0.434          P=0.686          P=0.454          P=0.571N                         | 
|POLY 1.5           |        P=0.454N         P=0.460          P=0.677          P=0.443          P=0.568N                         | 
|POLY 6             |        P=0.456N         P=0.404          P=0.692N         P=0.460          P=0.575N                         | 
|LOGISTIC REGRESSION|        P=0.400N         P=0.407          P=0.686          P=0.475          P=0.568N                         | 
|COCH-ARM / FISHERS |        P=0.450N         P=0.480          P=0.659          P=0.394          P=0.566N                         | 
|ORDER RESTRICTED   |        P=0.454N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 72      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/50 (24%)      3/49 (6%)        8/49 (16%)       3/36 (8%)        4/32 (13%)                       | 
|POLY-3 RATE (b)    |        12/40.25         3/31.56          8/33.78          3/21.09          4/21.42                          | 
|POLY-3 PERCENT (g) |        29.8%            9.5%             23.7%            14.2%            18.7%                            | 
|TERMINAL (d)       |        1/19 (5%)        1/21 (5%)        1/13 (8%)        0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        308              322              229              298              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.227N         P=0.028N*        P=0.349N         P=0.129N         P=0.229N                         | 
|POLY 3             |        P=0.203N         P=0.034N*        P=0.370N         P=0.157N         P=0.263N                         | 
|POLY 1.5           |        P=0.174N         P=0.025N*        P=0.317N         P=0.108N         P=0.234N                         | 
|POLY 6             |        P=0.248N         P=0.041N*        P=0.442N         P=0.233N         P=0.296N                         | 
|LOGISTIC REGRESSION|        P=0.112N         P=0.008N**       P=0.172N         P=0.033N*        P=0.105N                         | 
|COCH-ARM / FISHERS |        P=0.142N         P=0.013N*        P=0.242N         P=0.052N         P=0.160N                         | 
|ORDER RESTRICTED   |        P=0.200N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       6/48 (13%)       2/46 (4%)        3/40 (8%)        8/42 (19%)                       | 
|POLY-3 RATE (b)    |        6/35.74          6/32.04          2/34.11          3/32.19          8/31.07                          | 
|POLY-3 PERCENT (g) |        16.8%            18.7%            5.9%             9.3%             25.8%                            | 
|TERMINAL (d)       |        4/20 (20%)       3/18 (17%)       1/22 (5%)        2/20 (10%)       3/19 (16%)                       | 
|FIRST INCIDENCE    |        460              207              654              614              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.302          P=0.541          P=0.106N         P=0.246N         P=0.302                          | 
|POLY 3             |        P=0.264          P=0.544          P=0.143N         P=0.291N         P=0.273                          | 
|POLY 1.5           |        P=0.247          P=0.575          P=0.150N         P=0.306N         P=0.261                          | 
|POLY 6             |        P=0.280          P=0.509          P=0.132N         P=0.279N         P=0.297                          | 
|LOGISTIC REGRESSION|        P=0.233          P=0.554          P=0.135N         P=0.282N         P=0.247                          | 
|COCH-ARM / FISHERS |        P=0.216          P=0.591          P=0.163N         P=0.367N         P=0.259                          | 
|ORDER RESTRICTED   |        P=0.103          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 73      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       14/49 (29%)      17/49 (35%)      8/36 (22%)       9/32 (28%)                       | 
|POLY-3 RATE (b)    |        7/34.41          14/32.00         17/33.70         8/21.62          9/20.50                          | 
|POLY-3 PERCENT (g) |        20.4%            43.7%            50.5%            37.0%            43.9%                            | 
|TERMINAL (d)       |        3/19 (16%)       10/21 (48%)      5/13 (39%)       2/6 (33%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        463              418              481              483              539                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.045 *        P=0.081          P=0.005 **       P=0.059          P=0.045 *                        | 
|POLY 3             |        P=0.103          P=0.032 *        P=0.006 **       P=0.142          P=0.056                          | 
|POLY 1.5           |        P=0.126          P=0.035 *        P=0.007 **       P=0.171          P=0.061                          | 
|POLY 6             |        P=0.087          P=0.034 *        P=0.006 **       P=0.117          P=0.054                          | 
|LOGISTIC REGRESSION|        P=0.118          P=0.037 *        P=0.006 **       P=0.127          P=0.055                          | 
|COCH-ARM / FISHERS |        P=0.221          P=0.063          P=0.015 *        P=0.240          P=0.100                          | 
|ORDER RESTRICTED   |        P=0.060          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/50 (24%)      10/48 (21%)      9/46 (20%)       9/40 (23%)       11/42 (26%)                      | 
|POLY-3 RATE (b)    |        12/36.87         10/32.31         9/34.98          9/33.36          11/31.98                         | 
|POLY-3 PERCENT (g) |        32.5%            31.0%            25.7%            27.0%            34.4%                            | 
|TERMINAL (d)       |        7/20 (35%)       5/18 (28%)       4/22 (18%)       4/20 (20%)       5/19 (26%)                       | 
|FIRST INCIDENCE    |        372              500              514              510              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.517          P=0.545N         P=0.225N         P=0.335N         P=0.551                          | 
|POLY 3             |        P=0.491          P=0.547N         P=0.352N         P=0.401N         P=0.538                          | 
|POLY 1.5           |        P=0.442          P=0.496N         P=0.369N         P=0.433N         P=0.514                          | 
|POLY 6             |        P=0.528N         P=0.592N         P=0.318N         P=0.369N         P=0.576                          | 
|LOGISTIC REGRESSION|        P=0.420          P=0.546N         P=0.336N         P=0.419N         P=0.485                          | 
|COCH-ARM / FISHERS |        P=0.371          P=0.447N         P=0.391N         P=0.535N         P=0.499                          | 
|ORDER RESTRICTED   |        P=0.541          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 74      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/50 (30%)      16/49 (33%)      9/49 (18%)       10/36 (28%)      6/32 (19%)                       | 
|POLY-3 RATE (b)    |        15/38.25         16/35.08         9/32.05          10/24.29         6/22.30                          | 
|POLY-3 PERCENT (g) |        39.2%            45.6%            28.1%            41.2%            26.9%                            | 
|TERMINAL (d)       |        6/19 (32%)       8/21 (38%)       3/13 (23%)       2/6 (33%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        329              157              308              298              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.421N         P=0.493          P=0.317N         P=0.315          P=0.348N                         | 
|POLY 3             |        P=0.180N         P=0.373          P=0.229N         P=0.545          P=0.243N                         | 
|POLY 1.5           |        P=0.169N         P=0.387          P=0.185N         P=0.594          P=0.235N                         | 
|POLY 6             |        P=0.210N         P=0.381          P=0.295N         P=0.477          P=0.260N                         | 
|LOGISTIC REGRESSION|        P=0.154N         P=0.438          P=0.146N         P=0.528N         P=0.190N                         | 
|COCH-ARM / FISHERS |        P=0.139N         P=0.473          P=0.132N         P=0.509N         P=0.190N                         | 
|ORDER RESTRICTED   |        P=0.210N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       7/48 (15%)       9/46 (20%)       10/40 (25%)      7/42 (17%)                       | 
|POLY-3 RATE (b)    |        6/35.39          7/32.39          9/35.76          10/32.80         7/30.78                          | 
|POLY-3 PERCENT (g) |        17.0%            21.6%            25.2%            30.5%            22.7%                            | 
|TERMINAL (d)       |        4/20 (20%)       3/18 (17%)       6/22 (27%)       8/20 (40%)       4/19 (21%)                       | 
|FIRST INCIDENCE    |        577              341              332              488              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.300          P=0.411          P=0.354          P=0.191          P=0.424                          | 
|POLY 3             |        P=0.242          P=0.429          P=0.287          P=0.146          P=0.389                          | 
|POLY 1.5           |        P=0.215          P=0.455          P=0.264          P=0.132          P=0.375                          | 
|POLY 6             |        P=0.269          P=0.397          P=0.320          P=0.157          P=0.404                          | 
|LOGISTIC REGRESSION|        P=0.213          P=0.409          P=0.257          P=0.154          P=0.353                          | 
|COCH-ARM / FISHERS |        P=0.189          P=0.468          P=0.230          P=0.093          P=0.366                          | 
|ORDER RESTRICTED   |        P=0.297          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 75      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/49 (2%)        3/49 (6%)        0/36 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        1/33.13          1/31.27          3/30.44          0/19.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        3.0%             3.2%             9.9%             0.0%             0.0%                             | 
|TERMINAL (d)       |        1/19 (5%)        0/21 (0%)        1/13 (8%)        0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          157              308              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.309N         P=0.749N         P=0.235          P=0.729N         P=0.672N                         | 
|POLY 3             |        P=0.294N         P=0.749          P=0.273          P=0.599N         P=0.608N                         | 
|POLY 1.5           |        P=0.275N         P=0.747          P=0.282          P=0.587N         P=0.605N                         | 
|POLY 6             |        P=0.324N         P=0.755          P=0.259          P=0.615N         P=0.612N                         | 
|LOGISTIC REGRESSION|        P=0.219N         P=0.732N         P=0.297          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.240N         P=0.747          P=0.301          P=0.581N         P=0.610N                         | 
|ORDER RESTRICTED   |        P=0.322N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/48 (0%)        0/46 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/30.60          0/34.05          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/22 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 76      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/49 (2%)        1/49 (2%)        0/36 (0%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        1/33.92          1/30.28          1/28.97          0/19.93          1/19.62                          | 
|POLY-3 PERCENT (g) |        3.0%             3.3%             3.5%             0.0%             5.1%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        1/13 (8%)        0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        392              668 (T)          668 (T)          ---              538                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.495          P=0.755          P=0.707          P=0.593N         P=0.639                          | 
|POLY 3             |        P=0.557          P=0.736          P=0.726          P=0.604N         P=0.633                          | 
|POLY 1.5           |        P=0.567          P=0.738          P=0.738          P=0.590N         P=0.637                          | 
|POLY 6             |        P=0.543          P=0.739          P=0.708          P=0.621N         P=0.631                          | 
|LOGISTIC REGRESSION|        P=0.578          P=0.760          P=0.761          P=0.523N         P=0.690                          | 
|COCH-ARM / FISHERS |        P=0.593          P=0.747          P=0.747          P=0.581N         P=0.631                          | 
|ORDER RESTRICTED   |        P=0.552          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        7/48 (15%)       3/46 (7%)        2/40 (5%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        2/34.96          7/32.05          3/34.05          2/31.97          4/29.20                          | 
|POLY-3 PERCENT (g) |        5.7%             21.8%            8.8%             6.3%             13.7%                            | 
|TERMINAL (d)       |        2/20 (10%)       5/18 (28%)       3/22 (14%)       2/20 (10%)       3/19 (16%)                       | 
|FIRST INCIDENCE    |        668 (T)          341              668 (T)          668 (T)          565                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.493N         P=0.058          P=0.545          P=0.699          P=0.295                          | 
|POLY 3             |        P=0.544          P=0.054          P=0.488          P=0.664          P=0.253                          | 
|POLY 1.5           |        P=0.531          P=0.062          P=0.477          P=0.651          P=0.253                          | 
|POLY 6             |        P=0.553          P=0.046 *        P=0.505          P=0.673          P=0.256                          | 
|LOGISTIC REGRESSION|        P=0.543          P=0.054          P=0.545          P=0.699          P=0.250                          | 
|COCH-ARM / FISHERS |        P=0.498          P=0.070          P=0.460          P=0.603          P=0.259                          | 
|ORDER RESTRICTED   |        P=0.268          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 77      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Iliac                                                                                                                | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/12 (0%)        0/10 (0%)        1/15 (7%)        1/6 (17%)        0/2 (0%)                         | 
|POLY-3 RATE (b)    |        0/4.33           0/4.46           1/9.00           1/2.90           0/0.97                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             11.1%            34.5%            0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         1/3 (33%)        0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              668 (T)          647              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.219          (e)              P=0.718          P=0.331          (e)                              | 
|POLY 3             |        P=0.291          (e)              P=0.636          P=0.409          (e)                              | 
|POLY 1.5           |        P=0.263          (e)              P=0.599          P=0.384          (e)                              | 
|POLY 6             |        P=0.338          (e)              P=0.667          P=0.445          (e)                              | 
|LOGISTIC REGRESSION|        P=0.163          (e)              P=0.718          P=0.387          (e)                              | 
|COCH-ARM / FISHERS |        P=0.226          (e)              P=0.556          P=0.333          (e)                              | 
|ORDER RESTRICTED   |        P=0.589          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Iliac                                                                                                                | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/14 (0%)        2/23 (9%)        2/16 (13%)       0/12 (0%)        0/16 (0%)                        | 
|POLY-3 RATE (b)    |        0/5.53           2/13.28          2/11.79          0/9.59           0/11.87                          | 
|POLY-3 PERCENT (g) |        0.0%             15.1%            17.0%            0.0%             0.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         0/4 (0%)         0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              207              460              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.238N         P=0.239          P=0.253          (e)              (e)                              | 
|POLY 3             |        P=0.099N         P=0.447          P=0.421          (e)              (e)                              | 
|POLY 1.5           |        P=0.145N         P=0.410          P=0.351          (e)              (e)                              | 
|POLY 6             |        P=0.062N         P=0.501          P=0.515          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.345N         P=0.299          P=0.262          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.248N         P=0.380          P=0.276          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.387N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 78      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Inguinal                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/12 (17%)       0/10 (0%)        0/15 (0%)        0/6 (0%)         0/2 (0%)                         | 
|POLY-3 RATE (b)    |        2/6.22           0/4.46           0/9.00           0/2.81           0/0.97                           | 
|POLY-3 PERCENT (g) |        32.2%            0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         0/3 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        111              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.116N         P=0.252N         P=0.250N         P=0.319N         P=0.356N                         | 
|POLY 3             |        P=0.111N         P=0.294N         P=0.139N         P=0.417N         P=0.704N                         | 
|POLY 1.5           |        P=0.122N         P=0.277N         P=0.159N         P=0.413N         P=0.692N                         | 
|POLY 6             |        P=0.095N         P=0.350N         P=0.125N         P=0.427N         P=0.720N                         | 
|LOGISTIC REGRESSION|        P=0.172N         P=0.591N         P=0.221N         P=0.540N         P=0.853N                         | 
|COCH-ARM / FISHERS |        P=0.135N         P=0.286N         P=0.188N         P=0.431N         P=0.725N                         | 
|ORDER RESTRICTED   |        P=0.516N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Inguinal                                                                                                             | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/14 (7%)        0/23 (0%)        0/16 (0%)        0/12 (0%)        0/16 (0%)                        | 
|POLY-3 RATE (b)    |        1/6.08           0/12.26          0/10.79          0/9.59           0/11.87                          | 
|POLY-3 PERCENT (g) |        16.5%            0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         0/4 (0%)         0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        510              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.244N         P=0.541N         P=0.505N         P=0.522N         P=0.554N                         | 
|POLY 3             |        P=0.308N         P=0.360N         P=0.389N         P=0.412N         P=0.373N                         | 
|POLY 1.5           |        P=0.281N         P=0.373N         P=0.421N         P=0.457N         P=0.409N                         | 
|POLY 6             |        P=0.351N         P=0.347N         P=0.351N         P=0.361N         P=0.334N                         | 
|LOGISTIC REGRESSION|        P=0.255N         P=0.384N         P=0.471N         P=0.560N         P=0.495N                         | 
|COCH-ARM / FISHERS |        P=0.245N         P=0.378N         P=0.467N         P=0.538N         P=0.467N                         | 
|ORDER RESTRICTED   |        P=0.029N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 79      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Inguinal                                                                                                             | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/12 (17%)       1/10 (10%)       6/15 (40%)       1/6 (17%)        0/2 (0%)                         | 
|POLY-3 RATE (b)    |        2/6.02           1/4.46           6/11.42          1/3.72           0/0.97                           | 
|POLY-3 PERCENT (g) |        33.2%            22.4%            52.6%            26.9%            0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         1/1 (100%)       1/3 (33%)        0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        111              668 (T)          243              298              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.356N         P=0.513N         P=0.139          P=0.622N         P=0.354N                         | 
|POLY 3             |        P=0.502N         P=0.622N         P=0.399          P=0.695N         P=0.699N                         | 
|POLY 1.5           |        P=0.558N         P=0.582N         P=0.294          P=0.715N         P=0.687N                         | 
|POLY 6             |        P=0.450N         P=0.725N         P=0.492          P=0.690N         P=0.717N                         | 
|LOGISTIC REGRESSION|        P=0.567          P=0.619N         P=0.151          P=0.693          P=0.780N                         | 
|COCH-ARM / FISHERS |        P=0.581          P=0.571N         P=0.186          P=0.730          P=0.725N                         | 
|ORDER RESTRICTED   |        P=0.607N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Inguinal                                                                                                             | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/14 (14%)       4/23 (17%)       2/16 (13%)       1/12 (8%)        2/16 (13%)                       | 
|POLY-3 RATE (b)    |        2/7.16           4/14.28          2/12.19          1/9.59           2/13.18                          | 
|POLY-3 PERCENT (g) |        28.0%            28.0%            16.4%            10.4%            15.2%                            | 
|TERMINAL (d)       |        0/0 (0%)         1/4 (25%)        0/4 (0%)         0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        287              207              432              667              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.300N         P=0.468          P=0.689N         P=0.519N         P=0.629                          | 
|POLY 3             |        P=0.224N         P=0.692          P=0.491N         P=0.393N         P=0.460N                         | 
|POLY 1.5           |        P=0.277N         P=0.653          P=0.557N         P=0.456N         P=0.533N                         | 
|POLY 6             |        P=0.172N         P=0.669N         P=0.408N         P=0.313N         P=0.372N                         | 
|LOGISTIC REGRESSION|        P=0.487          P=0.498          P=0.584          P=0.733N         P=0.446                          | 
|COCH-ARM / FISHERS |        P=0.379N         P=0.593          P=0.648N         P=0.560N         P=0.648N                         | 
|ORDER RESTRICTED   |        P=0.419N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 80      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/12 (8%)        0/10 (0%)        0/15 (0%)        0/6 (0%)         0/2 (0%)                         | 
|POLY-3 RATE (b)    |        1/4.61           0/4.46           0/9.00           0/2.81           0/0.97                           | 
|POLY-3 PERCENT (g) |        21.7%            0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         0/3 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        601              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.288N         P=0.532N         P=0.541N         P=0.604N         P=0.617N                         | 
|POLY 3             |        P=0.372N         P=0.507N         P=0.370N         P=0.607N         P=0.838N                         | 
|POLY 1.5           |        P=0.358N         P=0.508N         P=0.403N         P=0.618N         P=0.838N                         | 
|POLY 6             |        P=0.375N         P=0.540N         P=0.349N         P=0.604N         P=0.842N                         | 
|LOGISTIC REGRESSION|        P=0.275N         P=0.510N         P=0.340N         P=0.577N         P=0.799N                         | 
|COCH-ARM / FISHERS |        P=0.328N         P=0.545N         P=0.444N         P=0.667N         P=0.857N                         | 
|ORDER RESTRICTED   |        P=0.548N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/14 (7%)        1/23 (4%)        2/16 (13%)       0/12 (0%)        1/16 (6%)                        | 
|POLY-3 RATE (b)    |        1/6.47           1/12.74          2/11.14          0/9.59           1/11.87                          | 
|POLY-3 PERCENT (g) |        15.5%            7.9%             18.0%            0.0%             8.4%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         0/4 (0%)         0/6 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        248              536              612              ---              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.353N         P=0.746          P=0.543          P=0.532N         P=0.537N                         | 
|POLY 3             |        P=0.338N         P=0.605N         P=0.688          P=0.423N         P=0.616N                         | 
|POLY 1.5           |        P=0.389N         P=0.622N         P=0.628          P=0.467N         P=0.665N                         | 
|POLY 6             |        P=0.282N         P=0.577N         P=0.698N         P=0.368N         P=0.548N                         | 
|LOGISTIC REGRESSION|        P=0.475N         P=0.730N         P=0.532          P=0.983N         P=0.719                          | 
|COCH-ARM / FISHERS |        P=0.475N         P=0.620N         P=0.552          P=0.538N         P=0.724N                         | 
|ORDER RESTRICTED   |        P=0.452N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 81      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/12 (0%)        0/10 (0%)        3/15 (20%)       0/6 (0%)         0/2 (0%)                         | 
|POLY-3 RATE (b)    |        0/4.33           0/4.46           3/9.49           0/2.81           0/0.97                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             31.6%            0.0%             0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         1/3 (33%)        0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              607              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.597          (e)              P=0.148          (e)              (e)                              | 
|POLY 3             |        P=0.648          (e)              P=0.284          (e)              (e)                              | 
|POLY 1.5           |        P=0.580          (e)              P=0.216          (e)              (e)                              | 
|POLY 6             |        P=0.652N         (e)              P=0.360          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.626          (e)              P=0.301          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.510          (e)              P=0.156          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.642          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/14 (7%)        2/23 (9%)        0/16 (0%)        1/12 (8%)        0/16 (0%)                        | 
|POLY-3 RATE (b)    |        1/6.51           2/13.39          0/10.79          1/9.59           0/11.87                          | 
|POLY-3 PERCENT (g) |        15.4%            14.9%            0.0%             10.4%            0.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         0/4 (0%)         1/6 (17%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        179              472              ---              668 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.158N         P=0.482          P=0.500N         P=0.540N         P=0.540N                         | 
|POLY 3             |        P=0.187N         P=0.731N         P=0.401N         P=0.670N         P=0.384N                         | 
|POLY 1.5           |        P=0.208N         P=0.712          P=0.433N         P=0.728N         P=0.420N                         | 
|POLY 6             |        P=0.169N         P=0.693N         P=0.359N         P=0.584N         P=0.340N                         | 
|LOGISTIC REGRESSION|        P=0.368N         P=0.577          (e)              P=0.570          (e)                              | 
|COCH-ARM / FISHERS |        P=0.248N         P=0.772N         P=0.467N         P=0.720          P=0.467N                         | 
|ORDER RESTRICTED   |        P=0.262N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 82      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/12 (0%)        0/10 (0%)        0/15 (0%)        0/6 (0%)         0/2 (0%)                         | 
|POLY-3 RATE (b)    |        0/4.33           0/4.46           0/9.00           0/2.81           0/0.97                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         0/3 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/14 (0%)        2/23 (9%)        1/16 (6%)        0/12 (0%)        0/16 (0%)                        | 
|POLY-3 RATE (b)    |        0/5.53           2/13.10          1/10.87          0/9.59           0/11.87                          | 
|POLY-3 PERCENT (g) |        0.0%             15.3%            9.2%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         0/4 (0%)         0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              549              650              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.253N         P=0.177          P=0.550          (e)              (e)                              | 
|POLY 3             |        P=0.130N         P=0.443          P=0.626          (e)              (e)                              | 
|POLY 1.5           |        P=0.170N         P=0.404          P=0.586          (e)              (e)                              | 
|POLY 6             |        P=0.094N         P=0.506          P=0.675          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.173N         P=0.410          P=0.895          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.256N         P=0.380          P=0.533          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.411N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 83      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/12 (8%)        0/10 (0%)        0/15 (0%)        1/6 (17%)        0/2 (0%)                         | 
|POLY-3 RATE (b)    |        1/4.61           0/4.46           0/9.00           1/2.90           0/0.97                           | 
|POLY-3 PERCENT (g) |        21.7%            0.0%             0.0%             34.5%            0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         0/3 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        601              ---              ---              647              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.626N         P=0.532N         P=0.541N         P=0.602          P=0.617N                         | 
|POLY 3             |        P=0.596          P=0.507N         P=0.370N         P=0.681          P=0.838N                         | 
|POLY 1.5           |        P=0.586          P=0.508N         P=0.403N         P=0.646          P=0.838N                         | 
|POLY 6             |        P=0.614          P=0.540N         P=0.349N         P=0.714          P=0.842N                         | 
|LOGISTIC REGRESSION|        P=0.660          P=0.510N         P=0.340N         P=0.728          P=0.799N                         | 
|COCH-ARM / FISHERS |        P=0.569          P=0.545N         P=0.444N         P=0.569          P=0.857N                         | 
|ORDER RESTRICTED   |        P=0.620N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/14 (0%)        3/23 (13%)       2/16 (13%)       0/12 (0%)        0/16 (0%)                        | 
|POLY-3 RATE (b)    |        0/5.53           3/14.15          2/11.54          0/9.59           0/11.87                          | 
|POLY-3 PERCENT (g) |        0.0%             21.2%            17.3%            0.0%             0.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/4 (0%)         0/4 (0%)         0/6 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              207              460              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.171N         P=0.123          P=0.270          (e)              (e)                              | 
|POLY 3             |        P=0.055N         P=0.329          P=0.415          (e)              (e)                              | 
|POLY 1.5           |        P=0.088N         P=0.283          P=0.348          (e)              (e)                              | 
|POLY 6             |        P=0.030N*        P=0.398          P=0.507          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.289N         P=0.144          P=0.310          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.176N         P=0.228          P=0.276          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.338N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 84      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          0/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/50 (18%)       9/50 (18%)       8/49 (16%)       6/40 (15%)       7/42 (17%)                       | 
|POLY-3 RATE (b)    |        9/37.83          9/34.73          8/39.31          6/32.95          7/31.10                          | 
|POLY-3 PERCENT (g) |        23.8%            25.9%            20.4%            18.2%            22.5%                            | 
|TERMINAL (d)       |        2/20 (10%)       1/18 (6%)        1/24 (4%)        2/20 (10%)       2/19 (11%)                       | 
|FIRST INCIDENCE    |        391              369              425              488              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.326N         P=0.466          P=0.425N         P=0.321N         P=0.544N                         | 
|POLY 3             |        P=0.376N         P=0.525          P=0.464N         P=0.389N         P=0.564N                         | 
|POLY 1.5           |        P=0.391N         P=0.565          P=0.485N         P=0.399N         P=0.562N                         | 
|POLY 6             |        P=0.367N         P=0.488          P=0.433N         P=0.389N         P=0.560N                         | 
|LOGISTIC REGRESSION|        P=0.412N         P=0.598          P=0.519N         P=0.438N         P=0.549N                         | 
|COCH-ARM / FISHERS |        P=0.417N         P=0.602N         P=0.518N         P=0.465N         P=0.545N                         | 
|ORDER RESTRICTED   |        P=0.567N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 85      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/1 (0%)         1/2 (50%)        0/0 (0%)         3/3 (100%)       0/1 (0%)                         | 
|POLY-3 RATE (b)    |        0/1.00           1/2.00           0/0.00           3/3.00           0/1.00                           | 
|POLY-3 PERCENT (g) |        0.0%             50.0%            0.0%             100.0%           0.0%                             | 
|TERMINAL (d)       |        0/1 (0%)         0/1 (0%)         0/0 (0%)         0/0 (0%)         0/1 (0%)                         | 
|FIRST INCIDENCE    |        ---              363              ---              434              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.185          P=0.479          (e)              P=0.039 *        (e)                              | 
|POLY 3             |        (e)              P=0.614          (e)              P=0.250N         (e)                              | 
|POLY 1.5           |        (e)              P=0.614          (e)              P=0.250N         (e)                              | 
|POLY 6             |        (e)              P=0.614          (e)              P=0.250N         (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.415          P=0.667          (e)              P=0.250          (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/4 (0%)         5/8 (63%)        4/7 (57%)        2/3 (67%)        3/5 (60%)                        | 
|POLY-3 RATE (b)    |        0/2.87           5/6.55           4/6.33           2/2.74           3/5.00                           | 
|POLY-3 PERCENT (g) |        0.0%             76.4%            63.2%            73.1%            60.0%                            | 
|TERMINAL (d)       |        0/0 (0%)         3/3 (100%)       2/3 (67%)        1/1 (100%)       2/4 (50%)                        | 
|FIRST INCIDENCE    |        ---              500              362              488              412                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.389N         P=0.184          P=0.251          P=0.495          P=0.475                          | 
|POLY 3             |        P=0.397          P=0.030 *        P=0.121          P=0.116          P=0.172                          | 
|POLY 1.5           |        P=0.277          P=0.034 *        P=0.099          P=0.101          P=0.126                          | 
|POLY 6             |        P=0.613N         P=0.047 *        P=0.187          P=0.158          P=0.276                          | 
|LOGISTIC REGRESSION|        P=0.176          P=0.057          P=0.113          P=0.145          P=0.102                          | 
|COCH-ARM / FISHERS |        P=0.182          P=0.071          P=0.106          P=0.143          P=0.119                          | 
|ORDER RESTRICTED   |        P=0.070          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 86      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/50 (2%)        1/50 (2%)        0/36 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        1/33.19          1/30.56          1/29.79          0/20.80          0/19.14                          | 
|POLY-3 PERCENT (g) |        3.0%             3.3%             3.4%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        654              624              474              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.259N         P=0.760          P=0.708          P=0.692N         P=0.648N                         | 
|POLY 3             |        P=0.245N         P=0.743          P=0.737          P=0.592N         P=0.609N                         | 
|POLY 1.5           |        P=0.235N         P=0.744          P=0.746          P=0.583N         P=0.605N                         | 
|POLY 6             |        P=0.261N         P=0.749          P=0.725          P=0.605N         P=0.613N                         | 
|LOGISTIC REGRESSION|        P=0.232N         P=0.748          P=0.755          P=0.635N         P=0.622N                         | 
|COCH-ARM / FISHERS |        P=0.220N         P=0.753N         P=0.753N         P=0.581N         P=0.610N                         | 
|ORDER RESTRICTED   |        P=0.426N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        0/50 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        2/35.04          0/31.04          0/36.65          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        5.7%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        651              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.083N         P=0.268N         P=0.202N         P=0.240N         P=0.262N                         | 
|POLY 3             |        P=0.089N         P=0.264N         P=0.226N         P=0.256N         P=0.281N                         | 
|POLY 1.5           |        P=0.093N         P=0.250N         P=0.231N         P=0.263N         P=0.280N                         | 
|POLY 6             |        P=0.086N         P=0.280N         P=0.219N         P=0.251N         P=0.281N                         | 
|LOGISTIC REGRESSION|        P=0.084N         P=0.280N         P=0.205N         P=0.242N         P=0.272N                         | 
|COCH-ARM / FISHERS |        P=0.099N         P=0.247N         P=0.247N         P=0.306N         P=0.293N                         | 
|ORDER RESTRICTED   |        P=0.028N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 87      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/50 (10%)       5/50 (10%)       5/50 (10%)       3/36 (8%)        4/32 (13%)                       | 
|POLY-3 RATE (b)    |        5/33.58          5/30.56          5/30.25          3/21.07          4/19.49                          | 
|POLY-3 PERCENT (g) |        14.9%            16.4%            16.5%            14.2%            20.5%                            | 
|TERMINAL (d)       |        3/19 (16%)       4/21 (19%)       3/13 (23%)       1/7 (14%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        565              624              474              607              627                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.195          P=0.591N         P=0.430          P=0.474          P=0.340                          | 
|POLY 3             |        P=0.391          P=0.572          P=0.566          P=0.626N         P=0.442                          | 
|POLY 1.5           |        P=0.410          P=0.579          P=0.591          P=0.598N         P=0.451                          | 
|POLY 6             |        P=0.362          P=0.581          P=0.531          P=0.641          P=0.433                          | 
|LOGISTIC REGRESSION|        P=0.356          P=0.597          P=0.531          P=0.622          P=0.420                          | 
|COCH-ARM / FISHERS |        P=0.458          P=0.630N         P=0.630N         P=0.552N         P=0.495                          | 
|ORDER RESTRICTED   |        P=0.535          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/50 (22%)      2/50 (4%)        7/50 (14%)       2/40 (5%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        11/35.72         2/31.69          7/38.60          2/32.58          4/29.55                          | 
|POLY-3 PERCENT (g) |        30.8%            6.3%             18.1%            6.1%             13.5%                            | 
|TERMINAL (d)       |        7/20 (35%)       1/18 (6%)        2/24 (8%)        1/20 (5%)        2/19 (11%)                       | 
|FIRST INCIDENCE    |        577              472              182              488              565                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.051N         P=0.018N*        P=0.137N         P=0.010N*        P=0.077N                         | 
|POLY 3             |        P=0.044N*        P=0.010N*        P=0.155N         P=0.008N**       P=0.083N                         | 
|POLY 1.5           |        P=0.057N         P=0.008N**       P=0.175N         P=0.011N*        P=0.087N                         | 
|POLY 6             |        P=0.035N*        P=0.013N*        P=0.129N         P=0.007N**       P=0.078N                         | 
|LOGISTIC REGRESSION|        P=0.069N         P=0.016N*        P=0.193N         P=0.011N*        P=0.090N                         | 
|COCH-ARM / FISHERS |        P=0.085N         P=0.007N**       P=0.218N         P=0.021N*        P=0.090N                         | 
|ORDER RESTRICTED   |        P=0.013N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 88      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/50 (2%)        4/49 (8%)        3/40 (8%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        1/34.96          1/31.44          4/36.89          3/32.69          4/29.41                          | 
|POLY-3 PERCENT (g) |        2.9%             3.2%             10.8%            9.2%             13.6%                            | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        2/24 (8%)        1/20 (5%)        2/19 (11%)                       | 
|FIRST INCIDENCE    |        668 (T)          565              612              539              593                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.071          P=0.706          P=0.243          P=0.297          P=0.146                          | 
|POLY 3             |        P=0.063          P=0.738          P=0.193          P=0.279          P=0.126                          | 
|POLY 1.5           |        P=0.056          P=0.749          P=0.185          P=0.265          P=0.125                          | 
|POLY 6             |        P=0.072          P=0.726          P=0.208          P=0.293          P=0.129                          | 
|LOGISTIC REGRESSION|        P=0.053          P=0.739          P=0.206          P=0.262          P=0.123                          | 
|COCH-ARM / FISHERS |        P=0.047 *        P=0.753N         P=0.175          P=0.229          P=0.131                          | 
|ORDER RESTRICTED   |        P=0.090          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 89      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        38/50 (76%)      35/50 (70%)      37/49 (76%)      29/40 (73%)      29/42 (69%)                      | 
|POLY-3 RATE (b)    |        38/43.53         35/44.59         37/45.21         29/36.51         29/34.65                         | 
|POLY-3 PERCENT (g) |        87.3%            78.5%            81.9%            79.4%            83.7%                            | 
|TERMINAL (d)       |        18/20 (90%)      10/18 (56%)      20/24 (83%)      16/20 (80%)      16/19 (84%)                      | 
|FIRST INCIDENCE    |        179              326              181              497              332                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.127N         P=0.421          P=0.239N         P=0.140N         P=0.276N                         | 
|POLY 3             |        P=0.434N         P=0.193N         P=0.329N         P=0.240N         P=0.444N                         | 
|POLY 1.5           |        P=0.386N         P=0.226N         P=0.399N         P=0.268N         P=0.399N                         | 
|POLY 6             |        P=0.521N         P=0.158N         P=0.269N         P=0.243N         P=0.516N                         | 
|LOGISTIC REGRESSION|        P=0.237N         P=0.380N         P=0.510N         P=0.186N         P=0.320N                         | 
|COCH-ARM / FISHERS |        P=0.306N         P=0.326N         P=0.570N         P=0.445N         P=0.304N                         | 
|ORDER RESTRICTED   |        P=0.385N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 90      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        2/50 (4%)        7/49 (14%)       5/40 (13%)       4/42 (10%)                       | 
|POLY-3 RATE (b)    |        2/35.30          2/32.42          7/38.54          5/32.69          4/28.81                          | 
|POLY-3 PERCENT (g) |        5.7%             6.2%             18.2%            15.3%            13.9%                            | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        3/24 (13%)       3/20 (15%)       4/19 (21%)                       | 
|FIRST INCIDENCE    |        581              395              432              539              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.182          P=0.634          P=0.118          P=0.202          P=0.294                          | 
|POLY 3             |        P=0.142          P=0.665          P=0.098          P=0.180          P=0.244                          | 
|POLY 1.5           |        P=0.133          P=0.680          P=0.088          P=0.169          P=0.249                          | 
|POLY 6             |        P=0.149          P=0.647          P=0.113          P=0.191          P=0.238                          | 
|LOGISTIC REGRESSION|        P=0.133          P=0.690N         P=0.080          P=0.175          P=0.251                          | 
|COCH-ARM / FISHERS |        P=0.123          P=0.691N         P=0.075          P=0.136          P=0.259                          | 
|ORDER RESTRICTED   |        P=0.178          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 91      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/49 (4%)        1/40 (3%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          2/36.54          1/31.97          1/29.11                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.5%             3.1%             3.4%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        2/24 (8%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              668 (T)          667              593                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.257          (e)              P=0.278          P=0.510          P=0.455                          | 
|POLY 3             |        P=0.252          (e)              P=0.246          P=0.482          P=0.463                          | 
|POLY 1.5           |        P=0.238          (e)              P=0.241          P=0.476          P=0.463                          | 
|POLY 6             |        P=0.268          (e)              P=0.255          P=0.487          P=0.465                          | 
|LOGISTIC REGRESSION|        P=0.235          (e)              P=0.278          P=0.506          P=0.463                          | 
|COCH-ARM / FISHERS |        P=0.216          (e)              P=0.242          P=0.444          P=0.457                          | 
|ORDER RESTRICTED   |        P=0.257          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 92      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        2/50 (4%)        2/37 (5%)        0/31 (0%)                        | 
|POLY-3 RATE (b)    |        1/33.77          0/30.37          2/29.55          2/21.66          0/18.96                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             6.8%             9.2%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        475              ---              607              531              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.484          P=0.523N         P=0.425          P=0.345          P=0.604N                         | 
|POLY 3             |        P=0.489          P=0.521N         P=0.453          P=0.348          P=0.614N                         | 
|POLY 1.5           |        P=0.490          P=0.518N         P=0.471          P=0.363          P=0.611N                         | 
|POLY 6             |        P=0.480          P=0.520N         P=0.431          P=0.330          P=0.618N                         | 
|LOGISTIC REGRESSION|        P=0.495          P=0.483N         P=0.482          P=0.391          P=0.578N                         | 
|COCH-ARM / FISHERS |        P=0.509          P=0.500N         P=0.500          P=0.387          P=0.617N                         | 
|ORDER RESTRICTED   |        P=0.405N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/49 (4%)        1/49 (2%)        0/40 (0%)        1/41 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          2/32.33          1/37.21          0/31.97          1/29.32                          | 
|POLY-3 PERCENT (g) |        0.0%             6.2%             2.7%             0.0%             3.4%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              326              460              ---              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.581          P=0.228          P=0.505          (e)              P=0.454                          | 
|POLY 3             |        P=0.599          P=0.219          P=0.512          (e)              P=0.465                          | 
|POLY 1.5           |        P=0.591          P=0.227          P=0.506          (e)              P=0.462                          | 
|POLY 6             |        P=0.603          P=0.210          P=0.522          (e)              P=0.468                          | 
|LOGISTIC REGRESSION|        P=0.556          P=0.223          P=0.478          (e)              P=0.466                          | 
|COCH-ARM / FISHERS |        P=0.562          P=0.242          P=0.495          (e)              P=0.451                          | 
|ORDER RESTRICTED   |        P=0.335          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 93      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        1/50 (2%)        1/37 (3%)        1/31 (3%)                        | 
|POLY-3 RATE (b)    |        1/33.40          2/31.54          1/29.31          1/21.21          1/19.14                          | 
|POLY-3 PERCENT (g) |        3.0%             6.3%             3.4%             4.7%             5.2%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        601              168              631              599              627                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.495          P=0.475          P=0.699          P=0.638          P=0.639                          | 
|POLY 3             |        P=0.494          P=0.480          P=0.732          P=0.655          P=0.632                          | 
|POLY 1.5           |        P=0.499          P=0.481          P=0.744          P=0.668          P=0.633                          | 
|POLY 6             |        P=0.485          P=0.487          P=0.716          P=0.638          P=0.629                          | 
|LOGISTIC REGRESSION|        P=0.520          P=0.535          P=0.734          P=0.665          P=0.635                          | 
|COCH-ARM / FISHERS |        P=0.526          P=0.500          P=0.753N         P=0.673          P=0.622                          | 
|ORDER RESTRICTED   |        P=0.622          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        4/49 (8%)        0/49 (0%)        2/40 (5%)        4/41 (10%)                       | 
|POLY-3 RATE (b)    |        0/34.96          4/33.58          0/36.54          2/33.10          4/31.19                          | 
|POLY-3 PERCENT (g) |        0.0%             11.9%            0.0%             6.0%             12.8%                            | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              326              ---              488              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.060          P=0.062          (e)              P=0.228          P=0.043 *                        | 
|POLY 3             |        P=0.061          P=0.053          (e)              P=0.223          P=0.044 *                        | 
|POLY 1.5           |        P=0.057          P=0.057          (e)              P=0.213          P=0.041 *                        | 
|POLY 6             |        P=0.064          P=0.049 *        (e)              P=0.233          P=0.048 *                        | 
|LOGISTIC REGRESSION|        P=0.045 *        P=0.053          (e)              P=0.119          P=0.043 *                        | 
|COCH-ARM / FISHERS |        P=0.049 *        P=0.056          (e)              P=0.195          P=0.038 *                        | 
|ORDER RESTRICTED   |        P=0.019 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 94      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Penis                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/0 (0%)         2/2 (100%)       1/1 (100%)       1/3 (33%)        0/1 (0%)                         | 
|POLY-3 RATE (b)    |        0/0.00           2/2.00           1/1.00           1/1.64           0/0.70                           | 
|POLY-3 PERCENT (g) |        0.0%             100.0%           100.0%           61.2%            0.0%                             | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              479              631              599              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.554N         (e)              (e)              P=0.370          (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.040N*        (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.057N         (e)              (e)              P=1.000          (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Penis                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 95      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/48 (0%)        0/49 (0%)        0/49 (0%)        0/36 (0%)        0/31 (0%)                        | 
|POLY-3 RATE (b)    |        0/32.18          0/30.26          0/28.40          0/20.80          0/18.74                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/49 (0%)        1/50 (2%)        1/40 (3%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.01          1/36.73          1/31.97          2/29.20                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.7%             3.1%             6.9%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        ---              ---              650              668 (T)          565                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.051          (e)              P=0.541          P=0.500          P=0.206                          | 
|POLY 3             |        P=0.052          (e)              P=0.510          P=0.482          P=0.196                          | 
|POLY 1.5           |        P=0.048 *        (e)              P=0.506          P=0.476          P=0.196                          | 
|POLY 6             |        P=0.055          (e)              P=0.517          P=0.487          P=0.198                          | 
|LOGISTIC REGRESSION|        P=0.045 *        (e)              P=0.519          P=0.500          P=0.196                          | 
|COCH-ARM / FISHERS |        P=0.042 *        (e)              P=0.500          P=0.444          P=0.206                          | 
|ORDER RESTRICTED   |        P=0.061          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 96      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/48 (2%)        2/49 (4%)        3/49 (6%)        2/36 (6%)        1/31 (3%)                        | 
|POLY-3 RATE (b)    |        1/32.66          2/30.78          3/29.02          2/21.38          1/19.04                          | 
|POLY-3 PERCENT (g) |        3.1%             6.5%             10.3%            9.4%             5.3%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        2/13 (15%)       1/7 (14%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        538              523              482              501              593                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.326          P=0.489          P=0.229          P=0.313          P=0.642                          | 
|POLY 3             |        P=0.391          P=0.479          P=0.261          P=0.354          P=0.635                          | 
|POLY 1.5           |        P=0.398          P=0.479          P=0.279          P=0.368          P=0.637                          | 
|POLY 6             |        P=0.382          P=0.487          P=0.241          P=0.335          P=0.635                          | 
|LOGISTIC REGRESSION|        P=0.412          P=0.490          P=0.277          P=0.379          P=0.652                          | 
|COCH-ARM / FISHERS |        P=0.443          P=0.508          P=0.316          P=0.392          P=0.634                          | 
|ORDER RESTRICTED   |        P=0.416          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        0/49 (0%)        0/50 (0%)        3/40 (8%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        3/35.88          0/31.01          0/36.65          3/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        8.4%             0.0%             0.0%             9.4%             0.0%                             | 
|TERMINAL (d)       |        2/20 (10%)       0/18 (0%)        0/24 (0%)        2/20 (10%)       0/19 (0%)                        | 
|FIRST INCIDENCE    |        287              ---              ---              667              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.325N         P=0.132N         P=0.100N         P=0.656          P=0.138N                         | 
|POLY 3             |        P=0.387N         P=0.145N         P=0.113N         P=0.610          P=0.159N                         | 
|POLY 1.5           |        P=0.394N         P=0.133N         P=0.116N         P=0.598          P=0.158N                         | 
|POLY 6             |        P=0.381N         P=0.159N         P=0.108N         P=0.619          P=0.160N                         | 
|LOGISTIC REGRESSION|        P=0.367N         P=0.122N         P=0.123N         P=0.588          P=0.151N                         | 
|COCH-ARM / FISHERS |        P=0.380N         P=0.125N         P=0.121N         P=0.550          P=0.156N                         | 
|ORDER RESTRICTED   |        P=0.057N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 97      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/48 (0%)        0/49 (0%)        0/49 (0%)        0/36 (0%)        0/31 (0%)                        | 
|POLY-3 RATE (b)    |        0/32.18          0/30.26          0/28.40          0/20.80          0/18.74                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        4/49 (8%)        1/50 (2%)        2/40 (5%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        3/35.30          4/31.12          1/36.65          2/32.22          4/29.43                          | 
|POLY-3 PERCENT (g) |        8.5%             12.9%            2.7%             6.2%             13.6%                            | 
|TERMINAL (d)       |        1/20 (5%)        3/18 (17%)       1/24 (4%)        1/20 (5%)        3/19 (16%)                       | 
|FIRST INCIDENCE    |        612              644              668 (T)          608              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.433          P=0.422          P=0.245N         P=0.504N         P=0.439                          | 
|POLY 3             |        P=0.390          P=0.430          P=0.290N         P=0.542N         P=0.399                          | 
|POLY 1.5           |        P=0.377          P=0.463          P=0.296N         P=0.556N         P=0.399                          | 
|POLY 6             |        P=0.396          P=0.392          P=0.281N         P=0.533N         P=0.399                          | 
|LOGISTIC REGRESSION|        P=0.391          P=0.388          P=0.272N         P=0.536N         P=0.394                          | 
|COCH-ARM / FISHERS |        P=0.348          P=0.489          P=0.309N         P=0.606N         P=0.402                          | 
|ORDER RESTRICTED   |        P=0.330          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 98      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       7/50 (14%)       6/50 (12%)       6/37 (16%)       2/32 (6%)                        | 
|POLY-3 RATE (b)    |        6/34.00          7/32.33          6/31.18          6/22.31          2/19.37                          | 
|POLY-3 PERCENT (g) |        17.7%            21.7%            19.2%            26.9%            10.3%                            | 
|TERMINAL (d)       |        3/19 (16%)       4/21 (19%)       1/13 (8%)        2/7 (29%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        497              329              481              382              627                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.520          P=0.510          P=0.433          P=0.133          P=0.447N                         | 
|POLY 3             |        P=0.413N         P=0.459          P=0.561          P=0.310          P=0.375N                         | 
|POLY 1.5           |        P=0.389N         P=0.456          P=0.582          P=0.340          P=0.364N                         | 
|POLY 6             |        P=0.449N         P=0.479          P=0.538          P=0.275          P=0.389N                         | 
|LOGISTIC REGRESSION|        P=0.384N         P=0.446          P=0.548          P=0.291          P=0.372N                         | 
|COCH-ARM / FISHERS |        P=0.327N         P=0.500          P=0.620N         P=0.398          P=0.326N                         | 
|ORDER RESTRICTED   |        P=0.338N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 99      
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/50 (22%)      11/50 (22%)      18/50 (36%)      8/37 (22%)       9/32 (28%)                       | 
|POLY-3 RATE (b)    |        11/34.90         11/32.88         18/35.14         8/23.90          9/21.47                          | 
|POLY-3 PERCENT (g) |        31.5%            33.5%            51.2%            33.5%            41.9%                            | 
|TERMINAL (d)       |        5/19 (26%)       5/21 (24%)       6/13 (46%)       2/7 (29%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        308              329              147              382              329                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.126          P=0.584N         P=0.024 *        P=0.260          P=0.193                          | 
|POLY 3             |        P=0.295          P=0.536          P=0.066          P=0.551          P=0.303                          | 
|POLY 1.5           |        P=0.303          P=0.530          P=0.074          P=0.565          P=0.299                          | 
|POLY 6             |        P=0.281          P=0.572          P=0.060          P=0.535          P=0.314                          | 
|LOGISTIC REGRESSION|        P=0.295          P=0.517          P=0.062          P=0.522          P=0.274                          | 
|COCH-ARM / FISHERS |        P=0.367          P=0.595N         P=0.093          P=0.590N         P=0.354                          | 
|ORDER RESTRICTED   |        P=0.339          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 100     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/50 (16%)       3/50 (6%)        12/50 (24%)      6/37 (16%)       5/32 (16%)                       | 
|POLY-3 RATE (b)    |        8/36.18          3/31.26          12/33.45         6/22.27          5/20.74                          | 
|POLY-3 PERCENT (g) |        22.1%            9.6%             35.9%            26.9%            24.1%                            | 
|TERMINAL (d)       |        1/19 (5%)        2/21 (10%)       4/13 (31%)       0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        104              322              413              580              376                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.204          P=0.123N         P=0.125          P=0.381          P=0.526                          | 
|POLY 3             |        P=0.275          P=0.144N         P=0.153          P=0.459          P=0.561                          | 
|POLY 1.5           |        P=0.292          P=0.134N         P=0.171          P=0.504          P=0.571                          | 
|POLY 6             |        P=0.253          P=0.150N         P=0.134          P=0.416          P=0.550                          | 
|LOGISTIC REGRESSION|        P=0.322          P=0.099N         P=0.214          P=0.568          P=0.612N                         | 
|COCH-ARM / FISHERS |        P=0.359          P=0.100N         P=0.227          P=0.601          P=0.633                          | 
|ORDER RESTRICTED   |        P=0.222          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 101     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        0/33.13          0/30.37          0/29.15          0/20.93          1/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             5.2%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.048 *        (e)              (e)              (e)              P=0.328                          | 
|POLY 3             |        P=0.082          (e)              (e)              (e)              P=0.391                          | 
|POLY 1.5           |        P=0.083          (e)              (e)              (e)              P=0.394                          | 
|POLY 6             |        P=0.081          (e)              (e)              (e)              P=0.387                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.328                          | 
|COCH-ARM / FISHERS |        P=0.086          (e)              (e)              (e)              P=0.390                          | 
|ORDER RESTRICTED   |        P=0.037 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        6/49 (12%)       3/49 (6%)        1/40 (3%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        2/35.24          6/33.81          3/36.00          1/31.97          4/30.13                          | 
|POLY-3 PERCENT (g) |        5.7%             17.7%            8.3%             3.1%             13.3%                            | 
|TERMINAL (d)       |        1/20 (5%)        1/18 (6%)        2/24 (8%)        1/20 (5%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        599              369              640              668 (T)          482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.534N         P=0.109          P=0.578          P=0.500N         P=0.264                          | 
|POLY 3             |        P=0.550          P=0.114          P=0.510          P=0.534N         P=0.263                          | 
|POLY 1.5           |        P=0.535          P=0.122          P=0.502          P=0.544N         P=0.259                          | 
|POLY 6             |        P=0.550N         P=0.106          P=0.526          P=0.529N         P=0.272                          | 
|LOGISTIC REGRESSION|        P=0.502          P=0.130          P=0.532          P=0.524N         P=0.254                          | 
|COCH-ARM / FISHERS |        P=0.494          P=0.128          P=0.490          P=0.584N         P=0.259                          | 
|ORDER RESTRICTED   |        P=0.259          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 102     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Infiltration Cellular Lymphoid                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        5/32 (16%)                       | 
|POLY-3 RATE (b)    |        1/33.13          0/30.37          0/29.15          0/20.93          5/20.04                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             0.0%             0.0%             25.0%                            | 
|TERMINAL (d)       |        1/19 (5%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         3/8 (38%)                        | 
|FIRST INCIDENCE    |        668 (T)          ---              ---              ---              495                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.480N         P=0.576N         P=0.699N         P=0.010 *                        | 
|POLY 3             |        P<0.001 **       P=0.517N         P=0.526N         P=0.590N         P=0.020 *                        | 
|POLY 1.5           |        P<0.001 **       P=0.516N         P=0.515N         P=0.580N         P=0.020 *                        | 
|POLY 6             |        P<0.001 **       P=0.514N         P=0.539N         P=0.604N         P=0.019 *                        | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.019 *                        | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500N         P=0.575N         P=0.031 *                        | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Infiltration Cellular Lymphoid                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/49 (0%)        0/49 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/30.96          0/35.88          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 103     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        1/50 (2%)        2/37 (5%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        1/33.13          0/30.37          1/29.15          2/21.09          0/19.14                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             3.4%             9.5%             0.0%                             | 
|TERMINAL (d)       |        1/19 (5%)        0/21 (0%)        1/13 (8%)        1/7 (14%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          ---              668 (T)          631              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.354          P=0.480N         P=0.676          P=0.204          P=0.672N                         | 
|POLY 3             |        P=0.482          P=0.517N         P=0.733          P=0.345          P=0.608N                         | 
|POLY 1.5           |        P=0.480          P=0.516N         P=0.744          P=0.362          P=0.605N                         | 
|POLY 6             |        P=0.481          P=0.514N         P=0.717          P=0.324          P=0.612N                         | 
|LOGISTIC REGRESSION|        P=0.413          (e)              P=0.676          P=0.264          (e)                              | 
|COCH-ARM / FISHERS |        P=0.495          P=0.500N         P=0.753N         P=0.387          P=0.610N                         | 
|ORDER RESTRICTED   |        P=0.442N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Infiltration Cellular Mixed Cell                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/49 (0%)        0/49 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/30.96          0/35.88          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 104     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Seminal Vesicle                                                                                                                  | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        3/32 (9%)                        | 
|POLY-3 RATE (b)    |        2/33.72          0/30.37          0/29.15          0/20.93          3/19.32                          | 
|POLY-3 PERCENT (g) |        5.9%             0.0%             0.0%             0.0%             15.5%                            | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         2/8 (25%)                        | 
|FIRST INCIDENCE    |        538              ---              ---              ---              627                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.056          P=0.256N         P=0.298N         P=0.384N         P=0.218                          | 
|POLY 3             |        P=0.087          P=0.260N         P=0.270N         P=0.350N         P=0.256                          | 
|POLY 1.5           |        P=0.092          P=0.256N         P=0.256N         P=0.333N         P=0.266                          | 
|POLY 6             |        P=0.079          P=0.259N         P=0.290N         P=0.373N         P=0.245                          | 
|LOGISTIC REGRESSION|        P=0.080          P=0.251N         P=0.255N         P=0.329N         P=0.255                          | 
|COCH-ARM / FISHERS |        P=0.097          P=0.247N         P=0.247N         P=0.327N         P=0.296                          | 
|ORDER RESTRICTED   |        P=0.012 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Seminal Vesicle                                                                                                                  | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 105     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Seminal Vesicle                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        3/50 (6%)        0/50 (0%)        3/37 (8%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        2/34.47          3/30.49          0/29.15          3/21.21          0/19.14                          | 
|POLY-3 PERCENT (g) |        5.8%             9.8%             0.0%             14.2%            0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        2/21 (10%)       0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        418              640              ---              631              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.512N         P=0.498          P=0.255N         P=0.234          P=0.368N                         | 
|POLY 3             |        P=0.412N         P=0.444          P=0.275N         P=0.286          P=0.376N                         | 
|POLY 1.5           |        P=0.400N         P=0.455          P=0.259N         P=0.314          P=0.368N                         | 
|POLY 6             |        P=0.429N         P=0.443          P=0.297N         P=0.256          P=0.387N                         | 
|LOGISTIC REGRESSION|        P=0.403N         P=0.476          P=0.218N         P=0.334          P=0.306N                         | 
|COCH-ARM / FISHERS |        P=0.368N         P=0.500          P=0.247N         P=0.359          P=0.369N                         | 
|ORDER RESTRICTED   |        P=0.247N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Seminal Vesicle                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 106     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Cyst Epithelial Inclusion                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/50 (0%)        1/37 (3%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          2/31.03          0/29.15          1/21.11          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             6.5%             0.0%             4.7%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              467              ---              625              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.590N         P=0.241          (e)              P=0.370          (e)                              | 
|POLY 3             |        P=0.570N         P=0.221          (e)              P=0.411          (e)                              | 
|POLY 1.5           |        P=0.562N         P=0.222          (e)              P=0.421          (e)                              | 
|POLY 6             |        P=0.578N         P=0.227          (e)              P=0.399          (e)                              | 
|LOGISTIC REGRESSION|        P=0.550N         P=0.228          (e)              P=0.400          (e)                              | 
|COCH-ARM / FISHERS |        P=0.533N         P=0.247          (e)              P=0.425          (e)                              | 
|ORDER RESTRICTED   |        P=0.433N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Cyst Epithelial Inclusion                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/49 (0%)        1/40 (3%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          0/36.54          1/32.58          2/29.92                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             3.1%             6.7%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              488              412                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.019 *        (e)              (e)              P=0.495          P=0.201                          | 
|POLY 3             |        P=0.021 *        (e)              (e)              P=0.486          P=0.201                          | 
|POLY 1.5           |        P=0.020 *        (e)              (e)              P=0.478          P=0.199                          | 
|POLY 6             |        P=0.023 *        (e)              (e)              P=0.493          P=0.205                          | 
|LOGISTIC REGRESSION|        P=0.018 *        (e)              (e)              P=0.374          P=0.206                          | 
|COCH-ARM / FISHERS |        P=0.017 *        (e)              (e)              P=0.444          P=0.206                          | 
|ORDER RESTRICTED   |        P=0.032 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 107     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/50 (20%)      2/50 (4%)        7/50 (14%)       7/37 (19%)       1/32 (3%)                        | 
|POLY-3 RATE (b)    |        10/38.55         2/31.55          7/30.92          7/22.84          1/19.92                          | 
|POLY-3 PERCENT (g) |        25.9%            6.3%             22.6%            30.7%            5.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        322              322              536              531              404                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.264N         P=0.032N*        P=0.463N         P=0.465          P=0.059N                         | 
|POLY 3             |        P=0.225N         P=0.030N*        P=0.485N         P=0.459          P=0.058N                         | 
|POLY 1.5           |        P=0.201N         P=0.024N*        P=0.409N         P=0.527          P=0.048N*                        | 
|POLY 6             |        P=0.270N         P=0.035N*        P=0.566N         P=0.400          P=0.074N                         | 
|LOGISTIC REGRESSION|        P=0.181N         P=0.011N*        P=0.301N         P=0.566N         P=0.022N*                        | 
|COCH-ARM / FISHERS |        P=0.170N         P=0.014N*        P=0.298N         P=0.562N         P=0.026N*                        | 
|ORDER RESTRICTED   |        P=0.051N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        7/50 (14%)       7/49 (14%)       6/40 (15%)       5/42 (12%)                       | 
|POLY-3 RATE (b)    |        3/37.45          7/35.64          7/40.09          6/34.17          5/32.19                          | 
|POLY-3 PERCENT (g) |        8.0%             19.6%            17.5%            17.6%            15.5%                            | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        248              290              362              414              43                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.337          P=0.140          P=0.186          P=0.209          P=0.271                          | 
|POLY 3             |        P=0.331          P=0.132          P=0.183          P=0.193          P=0.272                          | 
|POLY 1.5           |        P=0.319          P=0.144          P=0.167          P=0.179          P=0.273                          | 
|POLY 6             |        P=0.347          P=0.124          P=0.210          P=0.209          P=0.277                          | 
|LOGISTIC REGRESSION|        P=0.229          P=0.157          P=0.112          P=0.040 *        P=0.303                          | 
|COCH-ARM / FISHERS |        P=0.280          P=0.159          P=0.151          P=0.145          P=0.264                          | 
|ORDER RESTRICTED   |        P=0.236          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 108     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        14/50 (28%)      14/50 (28%)      13/50 (26%)      7/37 (19%)       6/32 (19%)                       | 
|POLY-3 RATE (b)    |        14/41.05         14/37.73         13/36.82         7/26.13          6/22.90                          | 
|POLY-3 PERCENT (g) |        34.1%            37.1%            35.3%            26.8%            26.2%                            | 
|TERMINAL (d)       |        3/19 (16%)       4/21 (19%)       1/13 (8%)        0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        111              147              229              167              192                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.251N         P=0.523          P=0.506          P=0.410N         P=0.370N                         | 
|POLY 3             |        P=0.187N         P=0.483          P=0.552          P=0.359N         P=0.355N                         | 
|POLY 1.5           |        P=0.157N         P=0.499          P=0.589N         P=0.310N         P=0.326N                         | 
|POLY 6             |        P=0.243N         P=0.482          P=0.496          P=0.430N         P=0.399N                         | 
|LOGISTIC REGRESSION|        P=0.057N         P=0.462N         P=0.371N         P=0.101N         P=0.136N                         | 
|COCH-ARM / FISHERS |        P=0.110N         P=0.588N         P=0.500N         P=0.235N         P=0.248N                         | 
|ORDER RESTRICTED   |        P=0.417N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Ulcer                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/50 (16%)       5/50 (10%)       1/49 (2%)        5/40 (13%)       3/42 (7%)                        | 
|POLY-3 RATE (b)    |        8/37.53          5/33.53          1/36.54          5/33.47          3/30.15                          | 
|POLY-3 PERCENT (g) |        21.3%            14.9%            2.7%             14.9%            10.0%                            | 
|TERMINAL (d)       |        3/20 (15%)       0/18 (0%)        1/24 (4%)        2/20 (10%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        255              207              668 (T)          488              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.173N         P=0.371N         P=0.014N*        P=0.319N         P=0.160N                         | 
|POLY 3             |        P=0.196N         P=0.348N         P=0.016N*        P=0.349N         P=0.175N                         | 
|POLY 1.5           |        P=0.207N         P=0.311N         P=0.016N*        P=0.368N         P=0.173N                         | 
|POLY 6             |        P=0.187N         P=0.386N         P=0.015N*        P=0.333N         P=0.177N                         | 
|LOGISTIC REGRESSION|        P=0.227N         P=0.264N         P=0.019N*        P=0.472N         P=0.162N                         | 
|COCH-ARM / FISHERS |        P=0.219N         P=0.277N         P=0.017N*        P=0.437N         P=0.164N                         | 
|ORDER RESTRICTED   |        P=0.104N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 109     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        13/50 (26%)      12/50 (24%)      12/50 (24%)      8/37 (22%)       5/32 (16%)                       | 
|POLY-3 RATE (b)    |        13/40.05         12/35.83         12/36.82         8/26.31          5/22.76                          | 
|POLY-3 PERCENT (g) |        32.5%            33.5%            32.6%            30.4%            22.0%                            | 
|TERMINAL (d)       |        3/19 (16%)       4/21 (19%)       0/13 (0%)        0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        308              254              229              167              192                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.297N         P=0.553N         P=0.520          P=0.578          P=0.318N                         | 
|POLY 3             |        P=0.211N         P=0.560          P=0.593          P=0.537N         P=0.277N                         | 
|POLY 1.5           |        P=0.185N         P=0.583          P=0.559N         P=0.486N         P=0.254N                         | 
|POLY 6             |        P=0.264N         P=0.554          P=0.545          P=0.604N         P=0.317N                         | 
|LOGISTIC REGRESSION|        P=0.097N         P=0.437N         P=0.388N         P=0.278N         P=0.118N                         | 
|COCH-ARM / FISHERS |        P=0.153N         P=0.500N         P=0.500N         P=0.416N         P=0.204N                         | 
|ORDER RESTRICTED   |        P=0.348N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       5/50 (10%)       3/49 (6%)        4/40 (10%)       3/42 (7%)                        | 
|POLY-3 RATE (b)    |        7/36.86          5/33.53          3/37.13          4/32.61          3/30.15                          | 
|POLY-3 PERCENT (g) |        19.0%            14.9%            8.1%             12.3%            10.0%                            | 
|TERMINAL (d)       |        2/20 (10%)       0/18 (0%)        2/24 (8%)        2/20 (10%)       1/19 (5%)                        | 
|FIRST INCIDENCE    |        460              207              495              488              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.169N         P=0.493N         P=0.127N         P=0.279N         P=0.238N                         | 
|POLY 3             |        P=0.194N         P=0.445N         P=0.149N         P=0.330N         P=0.245N                         | 
|POLY 1.5           |        P=0.205N         P=0.408N         P=0.154N         P=0.342N         P=0.243N                         | 
|POLY 6             |        P=0.190N         P=0.487N         P=0.143N         P=0.330N         P=0.250N                         | 
|LOGISTIC REGRESSION|        P=0.219N         P=0.377N         P=0.156N         P=0.361N         P=0.240N                         | 
|COCH-ARM / FISHERS |        P=0.219N         P=0.380N         P=0.167N         P=0.405N         P=0.239N                         | 
|ORDER RESTRICTED   |        P=0.236N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 110     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        31/49 (63%)      29/50 (58%)      27/50 (54%)      18/37 (49%)      20/32 (63%)                      | 
|POLY-3 RATE (b)    |        31/47.16         29/41.27         27/41.65         18/29.69         20/26.79                         | 
|POLY-3 PERCENT (g) |        65.7%            70.3%            64.8%            60.6%            74.7%                            | 
|TERMINAL (d)       |        7/18 (39%)       12/21 (57%)      5/13 (39%)       0/7 (0%)         6/8 (75%)                        | 
|FIRST INCIDENCE    |        104              147              147              167              41                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.266          P=0.474N         P=0.508          P=0.549N         P=0.324                          | 
|POLY 3             |        P=0.390          P=0.409          P=0.554N         P=0.416N         P=0.293                          | 
|POLY 1.5           |        P=0.498          P=0.504          P=0.430N         P=0.310N         P=0.387                          | 
|POLY 6             |        P=0.265          P=0.351          P=0.498          P=0.522N         P=0.198                          | 
|LOGISTIC REGRESSION|        P=0.330N         P=0.313N         P=0.142N         P=0.064N         P=0.482N                         | 
|COCH-ARM / FISHERS |        P=0.368N         P=0.371N         P=0.232N         P=0.128N         P=0.564N                         | 
|ORDER RESTRICTED   |        P=0.391          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        31/50 (62%)      21/50 (42%)      32/49 (65%)      26/40 (65%)      29/42 (69%)                      | 
|POLY-3 RATE (b)    |        31/43.75         21/38.39         32/43.18         26/37.62         29/36.68                         | 
|POLY-3 PERCENT (g) |        70.9%            54.7%            74.1%            69.1%            79.1%                            | 
|TERMINAL (d)       |        13/20 (65%)      7/18 (39%)       17/24 (71%)      11/20 (55%)      14/19 (74%)                      | 
|FIRST INCIDENCE    |        179              207              182              359              49                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.305          P=0.204N         P=0.388N         P=0.337N         P=0.429                          | 
|POLY 3             |        P=0.110          P=0.087N         P=0.459          P=0.530N         P=0.271                          | 
|POLY 1.5           |        P=0.078          P=0.054N         P=0.452          P=0.564N         P=0.267                          | 
|POLY 6             |        P=0.153          P=0.137N         P=0.491          P=0.509N         P=0.291                          | 
|LOGISTIC REGRESSION|        P=0.065          P=0.041N*        P=0.484          P=0.505          P=0.294                          | 
|COCH-ARM / FISHERS |        P=0.056          P=0.036N*        P=0.447          P=0.472          P=0.314                          | 
|ORDER RESTRICTED   |        P=0.083          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 111     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/49 (4%)        3/50 (6%)        4/50 (8%)        2/37 (5%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        2/32.24          3/30.89          4/30.90          2/22.05          0/19.14                          | 
|POLY-3 PERCENT (g) |        6.2%             9.7%             12.9%            9.1%             0.0%                             | 
|TERMINAL (d)       |        1/18 (6%)        2/21 (10%)       2/13 (15%)       0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        641              523              147              320              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.377N         P=0.529          P=0.239          P=0.426          P=0.427N                         | 
|POLY 3             |        P=0.275N         P=0.480          P=0.314          P=0.552          P=0.359N                         | 
|POLY 1.5           |        P=0.267N         P=0.479          P=0.329          P=0.564          P=0.356N                         | 
|POLY 6             |        P=0.293N         P=0.494          P=0.292          P=0.534          P=0.364N                         | 
|LOGISTIC REGRESSION|        P=0.243N         P=0.481          P=0.346          P=0.573          P=0.368N                         | 
|COCH-ARM / FISHERS |        P=0.235N         P=0.510          P=0.349          P=0.579          P=0.363N                         | 
|ORDER RESTRICTED   |        P=0.224N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        13/50 (26%)      24/50 (48%)      12/49 (24%)      10/40 (25%)      12/42 (29%)                      | 
|POLY-3 RATE (b)    |        13/38.73         24/39.56         12/40.21         10/33.81         12/32.91                         | 
|POLY-3 PERCENT (g) |        33.6%            60.7%            29.9%            29.6%            36.5%                            | 
|TERMINAL (d)       |        7/20 (35%)       11/18 (61%)      5/24 (21%)       6/20 (30%)       5/19 (26%)                       | 
|FIRST INCIDENCE    |        248              290              328              488              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.135N         P=0.014 *        P=0.380N         P=0.362N         P=0.541                          | 
|POLY 3             |        P=0.170N         P=0.010 *        P=0.454N         P=0.455N         P=0.497                          | 
|POLY 1.5           |        P=0.190N         P=0.013 *        P=0.487N         P=0.480N         P=0.482                          | 
|POLY 6             |        P=0.147N         P=0.009 **       P=0.401N         P=0.425N         P=0.526                          | 
|LOGISTIC REGRESSION|        P=0.231N         P=0.019 *        P=0.530N         P=0.552N         P=0.486                          | 
|COCH-ARM / FISHERS |        P=0.227N         P=0.019 *        P=0.523N         P=0.555N         P=0.482                          | 
|ORDER RESTRICTED   |        P=0.138N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 112     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/49 (8%)        5/50 (10%)       5/50 (10%)       7/37 (19%)       2/32 (6%)                        | 
|POLY-3 RATE (b)    |        4/34.81          5/34.01          5/31.51          7/25.40          2/19.67                          | 
|POLY-3 PERCENT (g) |        11.5%            14.7%            15.9%            27.6%            10.2%                            | 
|TERMINAL (d)       |        0/18 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        104              45               474              157              539                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.336          P=0.462          P=0.420          P=0.081          P=0.624N                         | 
|POLY 3             |        P=0.298          P=0.485          P=0.436          P=0.101          P=0.615N                         | 
|POLY 1.5           |        P=0.319          P=0.484          P=0.458          P=0.108          P=0.603N                         | 
|POLY 6             |        P=0.274          P=0.505          P=0.418          P=0.094          P=0.625N                         | 
|LOGISTIC REGRESSION|        P=0.477          P=0.598N         P=0.559          P=0.197          P=0.481N                         | 
|COCH-ARM / FISHERS |        P=0.401          P=0.513          P=0.513          P=0.125          P=0.555N                         | 
|ORDER RESTRICTED   |        P=0.398          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/50 (8%)        6/50 (12%)       5/49 (10%)       6/40 (15%)       4/42 (10%)                       | 
|POLY-3 RATE (b)    |        4/37.45          6/34.60          5/40.25          6/33.38          4/31.30                          | 
|POLY-3 PERCENT (g) |        10.7%            17.3%            12.4%            18.0%            12.8%                            | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        248              412              237              488              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.466          P=0.322          P=0.512          P=0.354          P=0.557                          | 
|POLY 3             |        P=0.434          P=0.317          P=0.546          P=0.294          P=0.543                          | 
|POLY 1.5           |        P=0.423          P=0.338          P=0.523          P=0.280          P=0.541                          | 
|POLY 6             |        P=0.444          P=0.305          P=0.577          P=0.310          P=0.548                          | 
|LOGISTIC REGRESSION|        P=0.371          P=0.393          P=0.410          P=0.147          P=0.590                          | 
|COCH-ARM / FISHERS |        P=0.406          P=0.370          P=0.487          P=0.237          P=0.541                          | 
|ORDER RESTRICTED   |        P=0.503          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 113     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        6/50 (12%)       5/50 (10%)       2/37 (5%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        0/32.13          6/30.37          5/29.30          2/21.09          1/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             19.8%            17.1%            9.5%             5.2%                             | 
|TERMINAL (d)       |        0/18 (0%)        6/21 (29%)       4/13 (31%)       1/7 (14%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        ---              668 (T)          633              631              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.340          P=0.023 *        P=0.011 *        P=0.083          P=0.338                          | 
|POLY 3             |        P=0.552          P=0.011 *        P=0.021 *        P=0.150          P=0.397                          | 
|POLY 1.5           |        P=0.542N         P=0.012 *        P=0.025 *        P=0.158          P=0.400                          | 
|POLY 6             |        P=0.530          P=0.011 *        P=0.017 *        P=0.139          P=0.394                          | 
|LOGISTIC REGRESSION|        P=0.452          P=0.023 *        P=0.012 *        P=0.117          P=0.338                          | 
|COCH-ARM / FISHERS |        P=0.475N         P=0.014 *        P=0.030 *        P=0.182          P=0.395                          | 
|ORDER RESTRICTED   |        P=0.108          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       3/50 (6%)        7/49 (14%)       6/40 (15%)       7/42 (17%)                       | 
|POLY-3 RATE (b)    |        7/36.24          3/32.79          7/37.23          6/32.44          7/30.09                          | 
|POLY-3 PERCENT (g) |        19.3%            9.2%             18.8%            18.5%            23.3%                            | 
|TERMINAL (d)       |        3/20 (15%)       1/18 (6%)        5/24 (21%)       5/20 (25%)       5/19 (26%)                       | 
|FIRST INCIDENCE    |        510              326              574              541              467                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.293          P=0.230N         P=0.511N         P=0.532N         P=0.513                          | 
|POLY 3             |        P=0.244          P=0.194N         P=0.595N         P=0.588N         P=0.464                          | 
|POLY 1.5           |        P=0.223          P=0.172N         P=0.607N         P=0.603N         P=0.465                          | 
|POLY 6             |        P=0.260          P=0.228N         P=0.577N         P=0.587N         P=0.458                          | 
|LOGISTIC REGRESSION|        P=0.221          P=0.165N         P=0.580N         P=0.573N         P=0.460                          | 
|COCH-ARM / FISHERS |        P=0.196          P=0.159N         P=0.597          P=0.563          P=0.472                          | 
|ORDER RESTRICTED   |        P=0.307          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 114     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/49 (2%)        0/50 (0%)        2/50 (4%)        1/37 (3%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        1/32.92          0/30.37          2/30.24          1/21.18          0/19.14                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             6.6%             4.7%             0.0%                             | 
|TERMINAL (d)       |        0/18 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        392              ---              490              607              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.520N         P=0.530N         P=0.474          P=0.651          P=0.616N                         | 
|POLY 3             |        P=0.533N         P=0.516N         P=0.470          P=0.658          P=0.607N                         | 
|POLY 1.5           |        P=0.522N         P=0.513N         P=0.483          P=0.672          P=0.602N                         | 
|POLY 6             |        P=0.552N         P=0.514N         P=0.455          P=0.642          P=0.612N                         | 
|LOGISTIC REGRESSION|        P=0.496N         P=0.453N         P=0.530          P=0.712          P=0.537N                         | 
|COCH-ARM / FISHERS |        P=0.501N         P=0.495N         P=0.508          P=0.678          P=0.605N                         | 
|ORDER RESTRICTED   |        P=0.446N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        5/50 (10%)       3/49 (6%)        2/40 (5%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        1/35.79          5/33.87          3/36.77          2/32.44          4/28.92                          | 
|POLY-3 PERCENT (g) |        2.8%             14.8%            8.2%             6.2%             13.8%                            | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        2/24 (8%)        1/20 (5%)        3/19 (16%)                       | 
|FIRST INCIDENCE    |        372              395              612              541              641                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.296          P=0.088          P=0.361          P=0.469          P=0.155                          | 
|POLY 3             |        P=0.260          P=0.086          P=0.314          P=0.465          P=0.116                          | 
|POLY 1.5           |        P=0.255          P=0.093          P=0.307          P=0.455          P=0.120                          | 
|POLY 6             |        P=0.264          P=0.081          P=0.326          P=0.474          P=0.113                          | 
|LOGISTIC REGRESSION|        P=0.243          P=0.109          P=0.300          P=0.346          P=0.126                          | 
|COCH-ARM / FISHERS |        P=0.239          P=0.102          P=0.301          P=0.416          P=0.131                          | 
|ORDER RESTRICTED   |        P=0.103          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 115     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/32.13          0/30.37          0/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/18 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/49 (0%)        0/40 (0%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          0/36.54          0/31.97          2/29.77                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             6.7%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              479                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.022 *        (e)              (e)              (e)              P=0.192                          | 
|POLY 3             |        P=0.025 *        (e)              (e)              (e)              P=0.200                          | 
|POLY 1.5           |        P=0.024 *        (e)              (e)              (e)              P=0.198                          | 
|POLY 6             |        P=0.026 *        (e)              (e)              (e)              P=0.204                          | 
|LOGISTIC REGRESSION|        P=0.020 *        (e)              (e)              (e)              P=0.202                          | 
|COCH-ARM / FISHERS |        P=0.020 *        (e)              (e)              (e)              P=0.206                          | 
|ORDER RESTRICTED   |        P=0.010 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 116     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/49 (4%)        0/50 (0%)        1/50 (2%)        1/37 (3%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        2/32.13          0/30.37          1/29.41          1/21.82          1/19.52                          | 
|POLY-3 PERCENT (g) |        6.2%             0.0%             3.4%             4.6%             5.1%                             | 
|TERMINAL (d)       |        2/18 (11%)       0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          ---              605              320              569                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.433          P=0.203N         P=0.595N         P=0.721          P=0.731                          | 
|POLY 3             |        P=0.517          P=0.248N         P=0.531N         P=0.634N         P=0.671N                         | 
|POLY 1.5           |        P=0.517          P=0.248N         P=0.517N         P=0.621N         P=0.669N                         | 
|POLY 6             |        P=0.512          P=0.242N         P=0.549N         P=0.651N         P=0.671N                         | 
|LOGISTIC REGRESSION|        P=0.507          (e)              P=0.570N         P=0.610N         P=0.683N                         | 
|COCH-ARM / FISHERS |        P=0.521          P=0.242N         P=0.492N         P=0.605N         P=0.657N                         | 
|ORDER RESTRICTED   |        P=0.504N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/50 (8%)        3/50 (6%)        0/49 (0%)        2/40 (5%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        4/36.11          3/32.31          0/36.54          2/32.34          4/31.57                          | 
|POLY-3 PERCENT (g) |        11.1%            9.3%             0.0%             6.2%             12.7%                            | 
|TERMINAL (d)       |        2/20 (10%)       0/18 (0%)        0/24 (0%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        372              500              ---              572              207                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.415          P=0.593N         P=0.054N         P=0.379N         P=0.544                          | 
|POLY 3             |        P=0.419          P=0.561N         P=0.057N         P=0.387N         P=0.569                          | 
|POLY 1.5           |        P=0.404          P=0.533N         P=0.059N         P=0.399N         P=0.560                          | 
|POLY 6             |        P=0.428          P=0.587N         P=0.054N         P=0.378N         P=0.580                          | 
|LOGISTIC REGRESSION|        P=0.357          P=0.508N         P=0.065N         P=0.434N         P=0.567                          | 
|COCH-ARM / FISHERS |        P=0.369          P=0.500N         P=0.061N         P=0.450N         P=0.541                          | 
|ORDER RESTRICTED   |        P=0.296          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 117     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/50 (0%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/32.88          0/30.37          0/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/49 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          2/31.52          0/36.54          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             6.3%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        1/18 (6%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              536              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.248N         P=0.212          (e)              (e)              (e)                              | 
|POLY 3             |        P=0.290N         P=0.214          (e)              (e)              (e)                              | 
|POLY 1.5           |        P=0.279N         P=0.225          (e)              (e)              (e)                              | 
|POLY 6             |        P=0.304N         P=0.203          (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.261N         P=0.219          (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.268N         P=0.247          (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.240N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 118     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        1/50 (2%)        2/50 (4%)        2/37 (5%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/32.88          1/30.37          2/29.86          2/21.27          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             3.3%             6.7%             9.4%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              668 (T)          544              625              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.368          P=0.520          P=0.197          P=0.106          (e)                              | 
|POLY 3             |        P=0.385          P=0.484          P=0.215          P=0.147          (e)                              | 
|POLY 1.5           |        P=0.393          P=0.487          P=0.225          P=0.157          (e)                              | 
|POLY 6             |        P=0.374          P=0.487          P=0.204          P=0.137          (e)                              | 
|LOGISTIC REGRESSION|        P=0.396          P=0.520          P=0.227          P=0.134          (e)                              | 
|COCH-ARM / FISHERS |        P=0.432          P=0.505          P=0.253          P=0.182          (e)                              | 
|ORDER RESTRICTED   |        P=0.288          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        1/49 (2%)        0/40 (0%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        0/34.96          2/32.51          1/37.21          0/31.97          2/29.57                          | 
|POLY-3 PERCENT (g) |        0.0%             6.2%             2.7%             0.0%             6.8%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              326              460              ---              474                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.292          P=0.232          P=0.505          (e)              P=0.207                          | 
|POLY 3             |        P=0.305          P=0.220          P=0.512          (e)              P=0.199                          | 
|POLY 1.5           |        P=0.297          P=0.229          P=0.506          (e)              P=0.198                          | 
|POLY 6             |        P=0.308          P=0.211          P=0.522          (e)              P=0.201                          | 
|LOGISTIC REGRESSION|        P=0.268          P=0.231          P=0.478          (e)              P=0.200                          | 
|COCH-ARM / FISHERS |        P=0.270          P=0.247          P=0.495          (e)              P=0.206                          | 
|ORDER RESTRICTED   |        P=0.093          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 119     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/49 (4%)        2/50 (4%)        1/50 (2%)        0/37 (0%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        2/34.35          2/31.41          1/29.91          0/20.93          1/19.62                          | 
|POLY-3 PERCENT (g) |        5.8%             6.4%             3.3%             0.0%             5.1%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        392              432              413              ---              539                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.339N         P=0.648          P=0.523N         P=0.341N         P=0.677N                         | 
|POLY 3             |        P=0.357N         P=0.663          P=0.548N         P=0.355N         P=0.689N                         | 
|POLY 1.5           |        P=0.335N         P=0.668          P=0.526N         P=0.335N         P=0.680N                         | 
|POLY 6             |        P=0.389N         P=0.668          P=0.576N         P=0.381N         P=0.697N                         | 
|LOGISTIC REGRESSION|        P=0.285N         P=0.655N         P=0.450N         P=0.260N         P=0.608N                         | 
|COCH-ARM / FISHERS |        P=0.305N         P=0.684N         P=0.492N         P=0.322N         P=0.657N                         | 
|ORDER RESTRICTED   |        P=0.491N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Erosion                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        1/49 (2%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        1/35.91          2/31.10          1/37.49          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        2.8%             6.4%             2.7%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        1/18 (6%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        255              655              237              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.119N         P=0.479          P=0.760          P=0.532N         P=0.537N                         | 
|POLY 3             |        P=0.135N         P=0.450          P=0.752N         P=0.523N         P=0.544N                         | 
|POLY 1.5           |        P=0.134N         P=0.473          P=0.757N         P=0.528N         P=0.542N                         | 
|POLY 6             |        P=0.138N         P=0.426          P=0.744N         P=0.520N         P=0.545N                         | 
|LOGISTIC REGRESSION|        P=0.140N         P=0.508          P=0.706          P=0.931N         P=0.461N                         | 
|COCH-ARM / FISHERS |        P=0.132N         P=0.500          P=0.747          P=0.556N         P=0.543N                         | 
|ORDER RESTRICTED   |        P=0.215N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 120     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular: Glands                                                                                                       | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/49 (18%)       13/50 (26%)      10/50 (20%)      15/37 (41%)      6/32 (19%)                       | 
|POLY-3 RATE (b)    |        9/33.42          13/32.85         10/30.42         15/25.57         6/20.17                          | 
|POLY-3 PERCENT (g) |        26.9%            39.6%            32.9%            58.7%            29.8%                            | 
|TERMINAL (d)       |        6/19 (32%)       9/21 (43%)       7/13 (54%)       5/7 (71%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        601              147              510              320              539                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.026 *        P=0.270          P=0.197          P<0.001 **       P=0.348                          | 
|POLY 3             |        P=0.160          P=0.196          P=0.401          P=0.009 **       P=0.537                          | 
|POLY 1.5           |        P=0.171          P=0.200          P=0.448          P=0.011 *        P=0.539                          | 
|POLY 6             |        P=0.150          P=0.210          P=0.343          P=0.007 **       P=0.541                          | 
|LOGISTIC REGRESSION|        P=0.153          P=0.170          P=0.290          P=0.006 **       P=0.485                          | 
|COCH-ARM / FISHERS |        P=0.244          P=0.251          P=0.520          P=0.022 *        P=0.593                          | 
|ORDER RESTRICTED   |        P=0.148          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular: Glands                                                                                                       | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       12/50 (24%)      8/49 (16%)       10/40 (25%)      6/42 (14%)                       | 
|POLY-3 RATE (b)    |        6/36.78          12/34.62         8/38.19          10/34.09         6/30.06                          | 
|POLY-3 PERCENT (g) |        16.3%            34.7%            21.0%            29.3%            20.0%                            | 
|TERMINAL (d)       |        0/20 (0%)        6/18 (33%)       4/24 (17%)       5/20 (25%)       4/19 (21%)                       | 
|FIRST INCIDENCE    |        443              326              362              488              479                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.468N         P=0.061          P=0.481          P=0.191          P=0.507                          | 
|POLY 3             |        P=0.488          P=0.060          P=0.413          P=0.149          P=0.474                          | 
|POLY 1.5           |        P=0.477          P=0.076          P=0.400          P=0.133          P=0.480                          | 
|POLY 6             |        P=0.487          P=0.047 *        P=0.429          P=0.159          P=0.462                          | 
|LOGISTIC REGRESSION|        P=0.488          P=0.082          P=0.387          P=0.108          P=0.486                          | 
|COCH-ARM / FISHERS |        P=0.462          P=0.096          P=0.371          P=0.093          P=0.492                          | 
|ORDER RESTRICTED   |        P=0.301          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 121     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/50 (8%)        7/50 (14%)       5/50 (10%)       3/37 (8%)        4/32 (13%)                       | 
|POLY-3 RATE (b)    |        4/33.45          7/31.35          5/30.77          3/21.68          4/19.54                          | 
|POLY-3 PERCENT (g) |        12.0%            22.3%            16.3%            13.8%            20.5%                            | 
|TERMINAL (d)       |        2/19 (11%)       4/21 (19%)       2/13 (15%)       1/7 (14%)        3/8 (38%)                        | 
|FIRST INCIDENCE    |        619              562              147              531              563                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.237          P=0.287          P=0.330          P=0.412          P=0.222                          | 
|POLY 3             |        P=0.396          P=0.216          P=0.446          P=0.582          P=0.332                          | 
|POLY 1.5           |        P=0.417          P=0.218          P=0.470          P=0.603          P=0.341                          | 
|POLY 6             |        P=0.365          P=0.231          P=0.414          P=0.555          P=0.322                          | 
|LOGISTIC REGRESSION|        P=0.405          P=0.213          P=0.455          P=0.547          P=0.309                          | 
|COCH-ARM / FISHERS |        P=0.477          P=0.262          P=0.500          P=0.641          P=0.379                          | 
|ORDER RESTRICTED   |        P=0.400          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/09/04                           EXPERIMENT: 99022 TEST: 02                                            Page 122     
Statistical Analysis of Non-neoplastic Lesions in       Mice(SWISS)  -          AZT TRANSPLACENTAL CARCINOGENESIS                   
                                         Terminal Sacrifice at 96 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/48 (31%)      12/45 (27%)      15/47 (32%)      13/33 (39%)      7/32 (22%)                       | 
|POLY-3 RATE (b)    |        15/37.70         12/35.05         15/34.91         13/25.81         7/21.66                          | 
|POLY-3 PERCENT (g) |        39.8%            34.2%            43.0%            50.4%            32.3%                            | 
|TERMINAL (d)       |        3/19 (16%)       2/18 (11%)       2/12 (17%)       0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        104              45               243              157              376                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.421          P=0.434N         P=0.372          P=0.195          P=0.437N                         | 
|POLY 3             |        P=0.474          P=0.401N         P=0.485          P=0.278          P=0.385N                         | 
|POLY 1.5           |        P=0.507          P=0.394N         P=0.512          P=0.285          P=0.355N                         | 
|POLY 6             |        P=0.434          P=0.419N         P=0.442          P=0.263          P=0.423N                         | 
|LOGISTIC REGRESSION|        P=0.359N         P=0.244N         P=0.582          P=0.353          P=0.253N                         | 
|COCH-ARM / FISHERS |        P=0.411N         P=0.399N         P=0.560          P=0.301          P=0.255N                         | 
|ORDER RESTRICTED   |        P=0.462N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0                50               100              200              300                              | 
|                   |        MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY         MG/KG/DY                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/49 (14%)       3/44 (7%)        5/46 (11%)       2/36 (6%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        7/38.61          3/30.14          5/38.16          2/29.78          4/32.18                          | 
|POLY-3 PERCENT (g) |        18.1%            10.0%            13.1%            6.7%             12.4%                            | 
|TERMINAL (d)       |        1/20 (5%)        0/17 (0%)        0/23 (0%)        0/19 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        105              412              237              641              49                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.257N         P=0.207N         P=0.347N         P=0.109N         P=0.366N                         | 
|POLY 3             |        P=0.243N         P=0.272N         P=0.385N         P=0.150N         P=0.371N                         | 
|POLY 1.5           |        P=0.258N         P=0.242N