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TDMS Study 99022-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                      AZT TRANSPLACENTAL CARCINOGENESIS STUDY                       DATE: 10/08/03       
EXPERIMENT: 99022 TEST: 02                                                                                     TIME: 15:46:56       
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/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 PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                      AZT TRANSPLACENTAL CARCINOGENESIS STUDY                       DATE: 10/08/03       
EXPERIMENT: 99022 TEST: 02                                                                                     TIME: 15:46:56       
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      
Mice(SWISS)                                                                                                                         
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Bone Marrow                                                                        
                                                 Brain                                                                              
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Salivary Glands                                                                    
                                                 Spleen                                                                             
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                      AZT TRANSPLACENTAL CARCINOGENESIS STUDY                       DATE: 10/08/03       
EXPERIMENT: 99022 TEST: 02                                                                                     TIME: 15:46:56       
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                                                                                    
-----                                 ----------                                                                                    
Lung                                   Alveolar/Bronchiolar Adenoma                                                                 
                                       Alveolar/Bronchiolar Carcinoma                                                               
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
All Organs                             Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Islets, Pancreatic                     Adenoma                                                                                      
===============================================================                                                                     
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 1       
                     Statistical Analysis of Primary Tumors 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                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        1/50 (2%)        3/37 (8%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        2/33.13          0/30.37          1/29.40          3/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        6.0%             0.0%             3.4%             14.3%            0.0%                             | 
|TERMINAL (d)       |        2/19 (11%)       0/21 (0%)        0/13 (0%)        3/7 (43%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        668 (T)          ---              608              668 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.349          P=0.215N         P=0.623N         P=0.102          P=0.442N                         | 
|POLY 3             |        P=0.528          P=0.256N         P=0.542N         P=0.296          P=0.366N                         | 
|POLY 1.5           |        P=0.523          P=0.254N         P=0.526N         P=0.320          P=0.362N                         | 
|POLY 6             |        P=0.528          P=0.251N         P=0.562N         P=0.265          P=0.371N                         | 
|LOGISTIC REGRESSION|        P=0.438          (e)              P=0.585N         P=0.102          (e)                              | 
|COCH-ARM / FISHERS |        P=0.535          P=0.247N         P=0.500N         P=0.359          P=0.369N                         | 
|ORDER RESTRICTED   |        P=0.297N         (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                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/49 (2%)        0/50 (0%)        0/38 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        1/35.30          1/30.04          0/36.65          0/29.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        2.8%             3.3%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        1/17 (6%)        0/24 (0%)        0/18 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        581              668 (T)          ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.156N         P=0.691          P=0.494N         P=0.540N         P=0.555N                         | 
|POLY 3             |        P=0.178N         P=0.725          P=0.493N         P=0.533N         P=0.541N                         | 
|POLY 1.5           |        P=0.176N         P=0.741          P=0.495N         P=0.537N         P=0.539N                         | 
|POLY 6             |        P=0.182N         P=0.705          P=0.487N         P=0.532N         P=0.543N                         | 
|LOGISTIC REGRESSION|        P=0.162N         P=0.726          P=0.498N         P=0.556N         P=0.537N                         | 
|COCH-ARM / FISHERS |        P=0.172N         P=0.747          P=0.500N         P=0.568N         P=0.543N                         | 
|ORDER RESTRICTED   |        P=0.235N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 2       
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Osteosarcoma or Osteoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone                                                                                                                             | 
|     Osteosarcoma or Osteoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/50 (0%)        1/40 (3%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          2/31.79          0/36.65          1/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             6.3%             0.0%             3.1%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              565              ---              668 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.444N         P=0.160          (e)              P=0.500          (e)                              | 
|POLY 3             |        P=0.504N         P=0.215          (e)              P=0.482          (e)                              | 
|POLY 1.5           |        P=0.493N         P=0.226          (e)              P=0.476          (e)                              | 
|POLY 6             |        P=0.516N         P=0.206          (e)              P=0.487          (e)                              | 
|LOGISTIC REGRESSION|        P=0.461N         P=0.231          (e)              P=0.500          (e)                              | 
|COCH-ARM / FISHERS |        P=0.471N         P=0.247          (e)              P=0.444          (e)                              | 
|ORDER RESTRICTED   |        P=0.334N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 3       
                     Statistical Analysis of Primary Tumors 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                                                                                                                  | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/50 (22%)      8/50 (16%)       9/50 (18%)       3/37 (8%)        4/32 (13%)                       | 
|POLY-3 RATE (b)    |        11/35.25         8/31.68          9/31.45          3/21.67          4/19.78                          | 
|POLY-3 PERCENT (g) |        31.2%            25.3%            28.6%            13.9%            20.2%                            | 
|TERMINAL (d)       |        5/19 (26%)       4/21 (19%)       3/13 (23%)       1/7 (14%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        453              523              413              501              488                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.283N         P=0.302N         P=0.521          P=0.291N         P=0.418N                         | 
|POLY 3             |        P=0.119N         P=0.393N         P=0.515N         P=0.122N         P=0.287N                         | 
|POLY 1.5           |        P=0.103N         P=0.381N         P=0.472N         P=0.101N         P=0.270N                         | 
|POLY 6             |        P=0.151N         P=0.377N         P=0.563N         P=0.155N         P=0.310N                         | 
|LOGISTIC REGRESSION|        P=0.114N         P=0.371N         P=0.507N         P=0.112N         P=0.267N                         | 
|COCH-ARM / FISHERS |        P=0.082N         P=0.306N         P=0.402N         P=0.071N         P=0.216N                         | 
|ORDER RESTRICTED   |        P=0.228N         (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                                                                                                                  | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/50 (8%)        6/50 (12%)       9/50 (18%)       4/40 (10%)       7/42 (17%)                       | 
|POLY-3 RATE (b)    |        4/35.91          6/31.40          9/37.13          4/32.36          7/30.54                          | 
|POLY-3 PERCENT (g) |        11.1%            19.1%            24.2%            12.4%            22.9%                            | 
|TERMINAL (d)       |        1/20 (5%)        5/18 (28%)       8/24 (33%)       3/20 (15%)       3/19 (16%)                       | 
|FIRST INCIDENCE    |        558              577              537              565              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.335          P=0.260          P=0.182          P=0.608          P=0.190                          | 
|POLY 3             |        P=0.294          P=0.283          P=0.121          P=0.587          P=0.167                          | 
|POLY 1.5           |        P=0.266          P=0.325          P=0.119          P=0.573          P=0.165                          | 
|POLY 6             |        P=0.318          P=0.237          P=0.126          P=0.593          P=0.172                          | 
|LOGISTIC REGRESSION|        P=0.268          P=0.267          P=0.137          P=0.584          P=0.162                          | 
|COCH-ARM / FISHERS |        P=0.221          P=0.370          P=0.117          P=0.512          P=0.170                          | 
|ORDER RESTRICTED   |        P=0.175          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 4       
                     Statistical Analysis of Primary Tumors 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                                                                                                                  | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        11/50 (22%)      8/50 (16%)       10/50 (20%)      3/37 (8%)        5/32 (16%)                       | 
|POLY-3 RATE (b)    |        11/35.25         8/31.68          10/31.45         3/21.67          5/20.60                          | 
|POLY-3 PERCENT (g) |        31.2%            25.3%            31.8%            13.9%            24.3%                            | 
|TERMINAL (d)       |        5/19 (26%)       4/21 (19%)       4/13 (31%)       1/7 (14%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        453              523              413              501              376                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.416N         P=0.302N         P=0.411          P=0.291N         P=0.563N                         | 
|POLY 3             |        P=0.196N         P=0.393N         P=0.586          P=0.122N         P=0.402N                         | 
|POLY 1.5           |        P=0.176N         P=0.381N         P=0.579N         P=0.101N         P=0.392N                         | 
|POLY 6             |        P=0.236N         P=0.377N         P=0.540          P=0.155N         P=0.420N                         | 
|LOGISTIC REGRESSION|        P=0.195N         P=0.371N         P=0.583          P=0.112N         P=0.398N                         | 
|COCH-ARM / FISHERS |        P=0.147N         P=0.306N         P=0.500N         P=0.071N         P=0.340N                         | 
|ORDER RESTRICTED   |        P=0.291N         (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                                                                                                                  | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/50 (8%)        6/50 (12%)       10/50 (20%)      4/40 (10%)       8/42 (19%)                       | 
|POLY-3 RATE (b)    |        4/35.91          6/31.40          10/37.49         4/32.36          8/30.54                          | 
|POLY-3 PERCENT (g) |        11.1%            19.1%            26.7%            12.4%            26.2%                            | 
|TERMINAL (d)       |        1/20 (5%)        5/18 (28%)       8/24 (33%)       3/20 (15%)       4/19 (21%)                       | 
|FIRST INCIDENCE    |        558              577              537              565              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.248          P=0.260          P=0.125          P=0.608          P=0.125                          | 
|POLY 3             |        P=0.211          P=0.283          P=0.078          P=0.587          P=0.098                          | 
|POLY 1.5           |        P=0.188          P=0.325          P=0.075          P=0.573          P=0.098                          | 
|POLY 6             |        P=0.231          P=0.237          P=0.084          P=0.593          P=0.101                          | 
|LOGISTIC REGRESSION|        P=0.187          P=0.267          P=0.087          P=0.584          P=0.097                          | 
|COCH-ARM / FISHERS |        P=0.151          P=0.370          P=0.074          P=0.512          P=0.105                          | 
|ORDER RESTRICTED   |        P=0.091          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 5       
                     Statistical Analysis of Primary Tumors 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                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)        0/36 (0%)        0/31 (0%)                        | 
|POLY-3 RATE (b)    |        1/33.89          0/30.37          0/29.15          0/19.93          0/18.96                          | 
|POLY-3 PERCENT (g) |        3.0%             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    |        413              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.284N         P=0.525N         P=0.515N         P=0.588N         P=0.620N                         | 
|POLY 3             |        P=0.282N         P=0.522N         P=0.530N         P=0.603N         P=0.614N                         | 
|POLY 1.5           |        P=0.272N         P=0.518N         P=0.518N         P=0.590N         P=0.611N                         | 
|POLY 6             |        P=0.300N         P=0.521N         P=0.545N         P=0.621N         P=0.619N                         | 
|LOGISTIC REGRESSION|        P=0.257N         P=0.462N         P=0.477N         P=0.528N         P=0.555N                         | 
|COCH-ARM / FISHERS |        P=0.273N         P=0.500N         P=0.500N         P=0.581N         P=0.617N                         | 
|ORDER RESTRICTED   |        P=0.230N         (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                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/49 (0%)        0/49 (0%)        1/40 (3%)        2/41 (5%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/30.96          0/36.54          1/31.97          2/29.09                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             3.1%             6.9%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              668 (T)          565                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.022 *        (e)              (e)              P=0.500          P=0.206                          | 
|POLY 3             |        P=0.020 *        (e)              (e)              P=0.482          P=0.195                          | 
|POLY 1.5           |        P=0.019 *        (e)              (e)              P=0.476          P=0.194                          | 
|POLY 6             |        P=0.021 *        (e)              (e)              P=0.487          P=0.197                          | 
|LOGISTIC REGRESSION|        P=0.018 *        (e)              (e)              P=0.500          P=0.194                          | 
|COCH-ARM / FISHERS |        P=0.017 *        (e)              (e)              P=0.444          P=0.200                          | 
|ORDER RESTRICTED   |        P=0.030 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 6       
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       4/50 (8%)        3/50 (6%)        1/37 (3%)        3/32 (9%)                        | 
|POLY-3 RATE (b)    |        7/36.30          4/31.83          3/30.02          1/21.18          3/20.40                          | 
|POLY-3 PERCENT (g) |        19.3%            12.6%            10.0%            4.7%             14.7%                            | 
|TERMINAL (d)       |        1/19 (5%)        1/21 (5%)        1/13 (8%)        0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        373              385              482              607              404                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.293N         P=0.316N         P=0.261N         P=0.148N         P=0.494N                         | 
|POLY 3             |        P=0.241N         P=0.337N         P=0.240N         P=0.131N         P=0.472N                         | 
|POLY 1.5           |        P=0.217N         P=0.321N         P=0.204N         P=0.107N         P=0.454N                         | 
|POLY 6             |        P=0.281N         P=0.339N         P=0.290N         P=0.166N         P=0.496N                         | 
|LOGISTIC REGRESSION|        P=0.200N         P=0.263N         P=0.162N         P=0.076N         P=0.384N                         | 
|COCH-ARM / FISHERS |        P=0.188N         P=0.262N         P=0.159N         P=0.072N         P=0.398N                         | 
|ORDER RESTRICTED   |        P=0.282N         (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                                                                                                                            | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        1/50 (2%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        1/34.96          0/31.04          1/36.65          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        2.9%             0.0%             2.7%             0.0%             0.0%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        1/24 (4%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        668 (T)          ---              668 (T)          ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.234N         P=0.521N         P=0.722N         P=0.500N         P=0.510N                         | 
|POLY 3             |        P=0.253N         P=0.524N         P=0.751N         P=0.518N         P=0.539N                         | 
|POLY 1.5           |        P=0.261N         P=0.512N         P=0.755N         P=0.524N         P=0.538N                         | 
|POLY 6             |        P=0.245N         P=0.536N         P=0.743N         P=0.513N         P=0.539N                         | 
|LOGISTIC REGRESSION|        P=0.234N         (e)              P=0.722N         (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.268N         P=0.500N         P=0.753N         P=0.556N         P=0.543N                         | 
|ORDER RESTRICTED   |        P=0.269N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 7       
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Hepatoblastoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        2/50 (4%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        1/33.74          0/30.37          2/30.16          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        3.0%             0.0%             6.6%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        488              ---              413              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.330N         P=0.524N         P=0.458          P=0.575N         P=0.593N                         | 
|POLY 3             |        P=0.346N         P=0.521N         P=0.461          P=0.594N         P=0.611N                         | 
|POLY 1.5           |        P=0.330N         P=0.518N         P=0.476          P=0.581N         P=0.607N                         | 
|POLY 6             |        P=0.372N         P=0.520N         P=0.441          P=0.609N         P=0.617N                         | 
|LOGISTIC REGRESSION|        P=0.306N         P=0.487N         P=0.514          P=0.546N         P=0.575N                         | 
|COCH-ARM / FISHERS |        P=0.311N         P=0.500N         P=0.500          P=0.575N         P=0.610N                         | 
|ORDER RESTRICTED   |        P=0.425N         (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                                                                                                                            | 
|     Hepatoblastoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 8       
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        14/50 (28%)      11/50 (22%)      10/50 (20%)      8/37 (22%)       4/32 (13%)                       | 
|POLY-3 RATE (b)    |        14/35.88         11/30.85         10/31.07         8/22.35          4/19.37                          | 
|POLY-3 PERCENT (g) |        39.0%            35.7%            32.2%            35.8%            20.7%                            | 
|TERMINAL (d)       |        8/19 (42%)       9/21 (43%)       4/13 (31%)       3/7 (43%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        446              595              505              483              627                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.377N         P=0.284N         P=0.530N         P=0.406          P=0.214N                         | 
|POLY 3             |        P=0.124N         P=0.488N         P=0.369N         P=0.512N         P=0.137N                         | 
|POLY 1.5           |        P=0.107N         P=0.442N         P=0.314N         P=0.445N         P=0.119N                         | 
|POLY 6             |        P=0.159N         P=0.515N         P=0.440N         P=0.593N         P=0.164N                         | 
|LOGISTIC REGRESSION|        P=0.127N         P=0.403N         P=0.355N         P=0.490N         P=0.111N                         | 
|COCH-ARM / FISHERS |        P=0.082N         P=0.322N         P=0.241N         P=0.337N         P=0.081N                         | 
|ORDER RESTRICTED   |        P=0.160N         (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                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        4/50 (8%)        5/50 (10%)       2/40 (5%)        4/42 (10%)                       | 
|POLY-3 RATE (b)    |        3/35.01          4/31.04          5/37.87          2/32.58          4/29.20                          | 
|POLY-3 PERCENT (g) |        8.6%             12.9%            13.2%            6.1%             13.7%                            | 
|TERMINAL (d)       |        2/20 (10%)       4/18 (22%)       2/24 (8%)        1/20 (5%)        3/19 (16%)                       | 
|FIRST INCIDENCE    |        658              668 (T)          514              488              565                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.539          P=0.437          P=0.439          P=0.498N         P=0.452                          | 
|POLY 3             |        P=0.511          P=0.433          P=0.399          P=0.533N         P=0.400                          | 
|POLY 1.5           |        P=0.485          P=0.467          P=0.380          P=0.551N         P=0.399                          | 
|POLY 6             |        P=0.534          P=0.397          P=0.432          P=0.519N         P=0.403                          | 
|LOGISTIC REGRESSION|        P=0.486          P=0.415          P=0.379          P=0.545N         P=0.396                          | 
|COCH-ARM / FISHERS |        P=0.436          P=0.500          P=0.357          P=0.606N         P=0.402                          | 
|ORDER RESTRICTED   |        P=0.452          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 9       
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Hepatocellular Carcinoma                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       6/50 (12%)       6/50 (12%)       4/37 (11%)       2/32 (6%)                        | 
|POLY-3 RATE (b)    |        6/35.11          6/31.38          6/31.52          4/22.29          2/20.40                          | 
|POLY-3 PERCENT (g) |        17.1%            19.1%            19.0%            17.9%            9.8%                             | 
|TERMINAL (d)       |        2/19 (11%)       4/21 (19%)       1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        392              444              413              483              473                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.387N         P=0.615          P=0.474          P=0.514          P=0.402N                         | 
|POLY 3             |        P=0.287N         P=0.542          P=0.545          P=0.607          P=0.365N                         | 
|POLY 1.5           |        P=0.275N         P=0.556          P=0.573          P=0.635N         P=0.359N                         | 
|POLY 6             |        P=0.307N         P=0.543          P=0.513          P=0.573          P=0.374N                         | 
|LOGISTIC REGRESSION|        P=0.267N         P=0.575          P=0.596          P=0.612N         P=0.325N                         | 
|COCH-ARM / FISHERS |        P=0.237N         P=0.620N         P=0.620N         P=0.571N         P=0.326N                         | 
|ORDER RESTRICTED   |        P=0.390N         (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                                                                                                                            | 
|     Hepatocellular Carcinoma                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        0/50 (0%)        0/40 (0%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        2/34.96          1/31.04          0/36.65          0/31.97          2/29.43                          | 
|POLY-3 PERCENT (g) |        5.7%             3.2%             0.0%             0.0%             6.8%                             | 
|TERMINAL (d)       |        2/20 (10%)       1/18 (6%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        668 (T)          668 (T)          ---              ---              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.567          P=0.537N         P=0.198N         P=0.237N         P=0.660                          | 
|POLY 3             |        P=0.562          P=0.542N         P=0.226N         P=0.255N         P=0.632                          | 
|POLY 1.5           |        P=0.548          P=0.521N         P=0.230N         P=0.263N         P=0.629                          | 
|POLY 6             |        P=0.571          P=0.564N         P=0.218N         P=0.250N         P=0.637                          | 
|LOGISTIC REGRESSION|        P=0.535          P=0.537N         (e)              (e)              P=0.625                          | 
|COCH-ARM / FISHERS |        P=0.510          P=0.500N         P=0.247N         P=0.306N         P=0.623                          | 
|ORDER RESTRICTED   |        P=0.251          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 10      
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       6/50 (12%)       6/50 (12%)       4/37 (11%)       2/32 (6%)                        | 
|POLY-3 RATE (b)    |        7/35.72          6/31.38          6/31.52          4/22.29          2/20.40                          | 
|POLY-3 PERCENT (g) |        19.6%            19.1%            19.0%            17.9%            9.8%                             | 
|TERMINAL (d)       |        2/19 (11%)       4/21 (19%)       1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        392              444              413              483              473                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.306N         P=0.509N         P=0.585          P=0.614          P=0.307N                         | 
|POLY 3             |        P=0.219N         P=0.603N         P=0.599N         P=0.573N         P=0.282N                         | 
|POLY 1.5           |        P=0.206N         P=0.580N         P=0.562N         P=0.532N         P=0.273N                         | 
|POLY 6             |        P=0.241N         P=0.611N         P=0.606          P=0.618N         P=0.294N                         | 
|LOGISTIC REGRESSION|        P=0.197N         P=0.545N         P=0.522N         P=0.491N         P=0.234N                         | 
|COCH-ARM / FISHERS |        P=0.174N         P=0.500N         P=0.500N         P=0.459N         P=0.236N                         | 
|ORDER RESTRICTED   |        P=0.337N         (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                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        0/50 (0%)        0/40 (0%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        2/34.96          1/31.04          0/36.65          0/31.97          2/29.43                          | 
|POLY-3 PERCENT (g) |        5.7%             3.2%             0.0%             0.0%             6.8%                             | 
|TERMINAL (d)       |        2/20 (10%)       1/18 (6%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        668 (T)          668 (T)          ---              ---              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.567          P=0.537N         P=0.198N         P=0.237N         P=0.660                          | 
|POLY 3             |        P=0.562          P=0.542N         P=0.226N         P=0.255N         P=0.632                          | 
|POLY 1.5           |        P=0.548          P=0.521N         P=0.230N         P=0.263N         P=0.629                          | 
|POLY 6             |        P=0.571          P=0.564N         P=0.218N         P=0.250N         P=0.637                          | 
|LOGISTIC REGRESSION|        P=0.535          P=0.537N         (e)              (e)              P=0.625                          | 
|COCH-ARM / FISHERS |        P=0.510          P=0.500N         P=0.247N         P=0.306N         P=0.623                          | 
|ORDER RESTRICTED   |        P=0.251          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 11      
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/50 (36%)      16/50 (32%)      16/50 (32%)      10/37 (27%)      6/32 (19%)                       | 
|POLY-3 RATE (b)    |        18/37.65         16/31.86         16/33.44         10/22.91         6/20.63                          | 
|POLY-3 PERCENT (g) |        47.8%            50.2%            47.9%            43.7%            29.1%                            | 
|TERMINAL (d)       |        9/19 (47%)       12/21 (57%)      5/13 (39%)       3/7 (43%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        392              444              413              483              473                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.328N         P=0.390N         P=0.410          P=0.451          P=0.225N                         | 
|POLY 3             |        P=0.083N         P=0.517          P=0.596          P=0.480N         P=0.130N                         | 
|POLY 1.5           |        P=0.069N         P=0.584          P=0.532N         P=0.392N         P=0.114N                         | 
|POLY 6             |        P=0.110N         P=0.472          P=0.542          P=0.578N         P=0.154N                         | 
|LOGISTIC REGRESSION|        P=0.076N         P=0.538N         P=0.540N         P=0.388N         P=0.104N                         | 
|COCH-ARM / FISHERS |        P=0.050N         P=0.417N         P=0.417N         P=0.258N         P=0.075N                         | 
|ORDER RESTRICTED   |        P=0.133N         (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                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/50 (10%)       5/50 (10%)       5/50 (10%)       2/40 (5%)        6/42 (14%)                       | 
|POLY-3 RATE (b)    |        5/35.01          5/31.04          5/37.87          2/32.58          6/29.83                          | 
|POLY-3 PERCENT (g) |        14.3%            16.1%            13.2%            6.1%             20.1%                            | 
|TERMINAL (d)       |        4/20 (20%)       5/18 (28%)       2/24 (8%)        1/20 (5%)        4/19 (21%)                       | 
|FIRST INCIDENCE    |        658              668 (T)          514              488              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.526          P=0.563          P=0.532N         P=0.215N         P=0.436                          | 
|POLY 3             |        P=0.501          P=0.555          P=0.582N         P=0.241N         P=0.385                          | 
|POLY 1.5           |        P=0.469          P=0.594          P=0.603N         P=0.260N         P=0.377                          | 
|POLY 6             |        P=0.527          P=0.510          P=0.544N         P=0.225N         P=0.398                          | 
|LOGISTIC REGRESSION|        P=0.462          P=0.544          P=0.598N         P=0.245N         P=0.362                          | 
|COCH-ARM / FISHERS |        P=0.406          P=0.630N         P=0.630N         P=0.320N         P=0.377                          | 
|ORDER RESTRICTED   |        P=0.329          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 12      
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/50 (36%)      16/50 (32%)      16/50 (32%)      10/37 (27%)      6/32 (19%)                       | 
|POLY-3 RATE (b)    |        18/37.65         16/31.86         16/33.44         10/22.91         6/20.63                          | 
|POLY-3 PERCENT (g) |        47.8%            50.2%            47.9%            43.7%            29.1%                            | 
|TERMINAL (d)       |        9/19 (47%)       12/21 (57%)      5/13 (39%)       3/7 (43%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        392              444              413              483              473                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.328N         P=0.390N         P=0.410          P=0.451          P=0.225N                         | 
|POLY 3             |        P=0.083N         P=0.517          P=0.596          P=0.480N         P=0.130N                         | 
|POLY 1.5           |        P=0.069N         P=0.584          P=0.532N         P=0.392N         P=0.114N                         | 
|POLY 6             |        P=0.110N         P=0.472          P=0.542          P=0.578N         P=0.154N                         | 
|LOGISTIC REGRESSION|        P=0.076N         P=0.538N         P=0.540N         P=0.388N         P=0.104N                         | 
|COCH-ARM / FISHERS |        P=0.050N         P=0.417N         P=0.417N         P=0.258N         P=0.075N                         | 
|ORDER RESTRICTED   |        P=0.133N         (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                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/50 (10%)       5/50 (10%)       5/50 (10%)       2/40 (5%)        6/42 (14%)                       | 
|POLY-3 RATE (b)    |        5/35.01          5/31.04          5/37.87          2/32.58          6/29.83                          | 
|POLY-3 PERCENT (g) |        14.3%            16.1%            13.2%            6.1%             20.1%                            | 
|TERMINAL (d)       |        4/20 (20%)       5/18 (28%)       2/24 (8%)        1/20 (5%)        4/19 (21%)                       | 
|FIRST INCIDENCE    |        658              668 (T)          514              488              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.526          P=0.563          P=0.532N         P=0.215N         P=0.436                          | 
|POLY 3             |        P=0.501          P=0.555          P=0.582N         P=0.241N         P=0.385                          | 
|POLY 1.5           |        P=0.469          P=0.594          P=0.603N         P=0.260N         P=0.377                          | 
|POLY 6             |        P=0.527          P=0.510          P=0.544N         P=0.225N         P=0.398                          | 
|LOGISTIC REGRESSION|        P=0.462          P=0.544          P=0.598N         P=0.245N         P=0.362                          | 
|COCH-ARM / FISHERS |        P=0.406          P=0.630N         P=0.630N         P=0.320N         P=0.377                          | 
|ORDER RESTRICTED   |        P=0.329          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 13      
                     Statistical Analysis of Primary Tumors 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/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/50 (20%)      13/50 (26%)      8/50 (16%)       9/37 (24%)       11/32 (34%)                      | 
|POLY-3 RATE (b)    |        10/34.53         13/34.83         8/31.51          9/24.48          11/23.96                         | 
|POLY-3 PERCENT (g) |        29.0%            37.3%            25.4%            36.8%            45.9%                            | 
|TERMINAL (d)       |        5/19 (26%)       5/21 (24%)       3/13 (23%)       2/7 (29%)        3/8 (38%)                        | 
|FIRST INCIDENCE    |        560              229              322              167              229                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.028 *        P=0.332          P=0.540          P=0.138          P=0.053                          | 
|POLY 3             |        P=0.109          P=0.311          P=0.480N         P=0.361          P=0.137                          | 
|POLY 1.5           |        P=0.102          P=0.288          P=0.446N         P=0.377          P=0.118                          | 
|POLY 6             |        P=0.105          P=0.356          P=0.532N         P=0.336          P=0.149                          | 
|LOGISTIC REGRESSION|        P=0.084          P=0.255          P=0.502N         P=0.327          P=0.092                          | 
|COCH-ARM / FISHERS |        P=0.105          P=0.318          P=0.398N         P=0.410          P=0.116                          | 
|ORDER RESTRICTED   |        P=0.150          (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/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       6/49 (12%)       8/50 (16%)       4/40 (10%)       7/42 (17%)                       | 
|POLY-3 RATE (b)    |        7/35.71          6/31.12          8/37.89          4/33.04          7/30.14                          | 
|POLY-3 PERCENT (g) |        19.6%            19.3%            21.1%            12.1%            23.2%                            | 
|TERMINAL (d)       |        4/20 (20%)       4/18 (22%)       4/24 (17%)       2/20 (10%)       5/19 (26%)                       | 
|FIRST INCIDENCE    |        573              644              432              359              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.480N         P=0.614          P=0.586N         P=0.288N         P=0.535                          | 
|POLY 3             |        P=0.522N         P=0.609N         P=0.551          P=0.301N         P=0.478                          | 
|POLY 1.5           |        P=0.523          P=0.559N         P=0.530          P=0.324N         P=0.473                          | 
|POLY 6             |        P=0.498N         P=0.579          P=0.585          P=0.287N         P=0.480                          | 
|LOGISTIC REGRESSION|        P=0.508          P=0.587          P=0.543          P=0.334N         P=0.458                          | 
|COCH-ARM / FISHERS |        P=0.454          P=0.516N         P=0.500          P=0.405N         P=0.472                          | 
|ORDER RESTRICTED   |        P=0.523          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 14      
                     Statistical Analysis of Primary Tumors 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/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/50 (10%)       11/50 (22%)      6/50 (12%)       11/37 (30%)      8/32 (25%)                       | 
|POLY-3 RATE (b)    |        5/33.64          11/33.29         6/30.23          11/24.41         8/20.69                          | 
|POLY-3 PERCENT (g) |        14.9%            33.0%            19.9%            45.1%            38.7%                            | 
|TERMINAL (d)       |        2/19 (11%)       5/21 (24%)       4/13 (31%)       3/7 (43%)        3/8 (38%)                        | 
|FIRST INCIDENCE    |        619              363              482              341              376                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.004 **       P=0.100          P=0.291          P=0.003 **       P=0.028 *                        | 
|POLY 3             |        P=0.014 *        P=0.068          P=0.422          P=0.009 **       P=0.043 *                        | 
|POLY 1.5           |        P=0.016 *        P=0.064          P=0.452          P=0.010 *        P=0.045 *                        | 
|POLY 6             |        P=0.012 *        P=0.082          P=0.380          P=0.008 **       P=0.041 *                        | 
|LOGISTIC REGRESSION|        P=0.015 *        P=0.060          P=0.381          P=0.008 **       P=0.038 *                        | 
|COCH-ARM / FISHERS |        P=0.028 *        P=0.086          P=0.500          P=0.020 *        P=0.068                          | 
|ORDER RESTRICTED   |        P=0.026 *        (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/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/50 (10%)       6/49 (12%)       8/50 (16%)       8/40 (20%)       5/42 (12%)                       | 
|POLY-3 RATE (b)    |        5/35.35          6/32.12          8/37.19          8/33.10          5/29.11                          | 
|POLY-3 PERCENT (g) |        14.2%            18.7%            21.5%            24.2%            17.2%                            | 
|TERMINAL (d)       |        3/20 (15%)       3/18 (17%)       7/24 (29%)       5/20 (25%)       4/19 (21%)                       | 
|FIRST INCIDENCE    |        599              560              514              539              593                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.445          P=0.369          P=0.388          P=0.263          P=0.566                          | 
|POLY 3             |        P=0.356          P=0.431          P=0.304          P=0.225          P=0.504                          | 
|POLY 1.5           |        P=0.337          P=0.461          P=0.292          P=0.203          P=0.506                          | 
|POLY 6             |        P=0.372          P=0.403          P=0.325          P=0.246          P=0.503                          | 
|LOGISTIC REGRESSION|        P=0.378          P=0.389          P=0.329          P=0.218          P=0.509                          | 
|COCH-ARM / FISHERS |        P=0.317          P=0.486          P=0.277          P=0.149          P=0.514                          | 
|ORDER RESTRICTED   |        P=0.424          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 15      
                     Statistical Analysis of Primary Tumors 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/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        14/50 (28%)      20/50 (40%)      13/50 (26%)      18/37 (49%)      18/32 (56%)                      | 
|POLY-3 RATE (b)    |        14/34.86         20/36.71         13/32.14         18/27.17         18/24.68                         | 
|POLY-3 PERCENT (g) |        40.2%            54.5%            40.5%            66.3%            72.9%                            | 
|TERMINAL (d)       |        7/19 (37%)       9/21 (43%)       7/13 (54%)       5/7 (71%)        6/8 (75%)                        | 
|FIRST INCIDENCE    |        560              229              322              167              229                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.178          P=0.323          P=0.002 **       P=0.003 **                       | 
|POLY 3             |        P=0.002 **       P=0.156          P=0.592          P=0.027 *        P=0.007 **                       | 
|POLY 1.5           |        P=0.002 **       P=0.127          P=0.565N         P=0.028 *        P=0.005 **                       | 
|POLY 6             |        P=0.002 **       P=0.212          P=0.528          P=0.027 *        P=0.009 **                       | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.087          P=0.521          P=0.014 *        P=0.003 **                       | 
|COCH-ARM / FISHERS |        P=0.003 **       P=0.146          P=0.500N         P=0.040 *        P=0.010 *                        | 
|ORDER RESTRICTED   |        P=0.008 **       (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/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/50 (20%)      11/49 (22%)      14/50 (28%)      12/40 (30%)      11/42 (26%)                      | 
|POLY-3 RATE (b)    |        10/36.09         11/32.28         14/38.44         12/34.17         11/30.44                         | 
|POLY-3 PERCENT (g) |        27.7%            34.1%            36.4%            35.1%            36.1%                            | 
|TERMINAL (d)       |        5/20 (25%)       6/18 (33%)       9/24 (38%)       7/20 (35%)       8/19 (42%)                       | 
|FIRST INCIDENCE    |        573              560              432              359              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.379          P=0.324          P=0.402          P=0.376          P=0.391                          | 
|POLY 3             |        P=0.296          P=0.377          P=0.286          P=0.338          P=0.315                          | 
|POLY 1.5           |        P=0.260          P=0.432          P=0.266          P=0.298          P=0.315                          | 
|POLY 6             |        P=0.323          P=0.319          P=0.319          P=0.370          P=0.311                          | 
|LOGISTIC REGRESSION|        P=0.268          P=0.313          P=0.281          P=0.292          P=0.297                          | 
|COCH-ARM / FISHERS |        P=0.213          P=0.479          P=0.241          P=0.197          P=0.324                          | 
|ORDER RESTRICTED   |        P=0.410          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 16      
                     Statistical Analysis of Primary Tumors 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                                                                                                                       | 
|     Plasma Cell Tumor Malignant                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node                                                                                                                       | 
|     Plasma Cell Tumor Malignant                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        1/50 (2%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          2/32.17          1/37.63          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             6.2%             2.7%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              441              182              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.259N         P=0.204          P=0.504          (e)              (e)                              | 
|POLY 3             |        P=0.272N         P=0.218          P=0.515          (e)              (e)                              | 
|POLY 1.5           |        P=0.269N         P=0.227          P=0.510          (e)              (e)                              | 
|POLY 6             |        P=0.275N         P=0.209          P=0.523          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.264N         P=0.244          P=0.381          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.267N         P=0.247          P=0.500          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.336N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 17      
                     Statistical Analysis of Primary Tumors 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                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        2/50 (4%)        2/50 (4%)        1/40 (3%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        2/35.44          2/31.04          2/37.47          1/32.07          1/29.15                          | 
|POLY-3 PERCENT (g) |        5.6%             6.4%             5.3%             3.1%             3.4%                             | 
|TERMINAL (d)       |        0/20 (0%)        2/18 (11%)       0/24 (0%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        573              668 (T)          425              646              580                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.299N         P=0.619          P=0.661N         P=0.535N         P=0.582N                         | 
|POLY 3             |        P=0.322N         P=0.647          P=0.675N         P=0.535N         P=0.568N                         | 
|POLY 1.5           |        P=0.330N         P=0.671          P=0.682N         P=0.544N         P=0.567N                         | 
|POLY 6             |        P=0.316N         P=0.618          P=0.663N         P=0.530N         P=0.570N                         | 
|LOGISTIC REGRESSION|        P=0.325N         P=0.634          P=0.694N         P=0.542N         P=0.566N                         | 
|COCH-ARM / FISHERS |        P=0.343N         P=0.691N         P=0.691N         P=0.584N         P=0.566N                         | 
|ORDER RESTRICTED   |        P=0.534N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 18      
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Cystadenoma                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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                                                                                                                            | 
|     Cystadenoma                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        2/49 (4%)        0/40 (0%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        2/35.80          1/31.04          2/36.60          0/31.97          1/28.91                          | 
|POLY-3 PERCENT (g) |        5.6%             3.2%             5.5%             0.0%             3.5%                             | 
|TERMINAL (d)       |        0/20 (0%)        1/18 (6%)        1/24 (4%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        510              668 (T)          654              ---              645                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.267N         P=0.569N         P=0.647N         P=0.254N         P=0.579N                         | 
|POLY 3             |        P=0.278N         P=0.550N         P=0.687N         P=0.261N         P=0.575N                         | 
|POLY 1.5           |        P=0.290N         P=0.525N         P=0.692N         P=0.266N         P=0.570N                         | 
|POLY 6             |        P=0.271N         P=0.578N         P=0.680N         P=0.259N         P=0.580N                         | 
|LOGISTIC REGRESSION|        P=0.288N         P=0.521N         P=0.690N         P=0.305N         P=0.564N                         | 
|COCH-ARM / FISHERS |        P=0.310N         P=0.500N         P=0.684          P=0.306N         P=0.566N                         | 
|ORDER RESTRICTED   |        P=0.357N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 19      
                     Statistical Analysis of Primary Tumors 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                                                                                                                            | 
|     Granulosa Cell Tumor Malignant                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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                                                                                                                            | 
|     Granulosa Cell Tumor Malignant                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/49 (0%)        2/40 (5%)        1/42 (2%)                        | 
|POLY-3 RATE (b)    |        0/34.96          0/31.04          0/36.54          2/32.46          1/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             6.2%             3.5%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              565              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.068          (e)              (e)              P=0.219          P=0.490                          | 
|POLY 3             |        P=0.059          (e)              (e)              P=0.219          P=0.461                          | 
|POLY 1.5           |        P=0.058          (e)              (e)              P=0.211          P=0.462                          | 
|POLY 6             |        P=0.061          (e)              (e)              P=0.226          P=0.461                          | 
|LOGISTIC REGRESSION|        P=0.061          (e)              (e)              P=0.201          P=0.490                          | 
|COCH-ARM / FISHERS |        P=0.058          (e)              (e)              P=0.195          P=0.457                          | 
|ORDER RESTRICTED   |        P=0.125          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 20      
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        0/50 (0%)        1/37 (3%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          1/31.33          0/29.15          1/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             0.0%             4.8%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        1/7 (14%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              229              ---              668 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.502          P=0.492          (e)              P=0.301          (e)                              | 
|POLY 3             |        P=0.548          P=0.489          (e)              P=0.409          (e)                              | 
|POLY 1.5           |        P=0.544          P=0.489          (e)              P=0.420          (e)                              | 
|POLY 6             |        P=0.555          P=0.494          (e)              P=0.395          (e)                              | 
|LOGISTIC REGRESSION|        P=0.584          P=0.607          (e)              P=0.301          (e)                              | 
|COCH-ARM / FISHERS |        P=0.566          P=0.500          (e)              P=0.425          (e)                              | 
|ORDER RESTRICTED   |        P=0.444          (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                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        0/50 (0%)        1/40 (3%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        2/35.19          1/31.15          0/36.65          1/32.49          0/28.81                          | 
|POLY-3 PERCENT (g) |        5.7%             3.2%             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    |        612              644              ---              523              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.165N         P=0.559N         P=0.194N         P=0.510N         P=0.265N                         | 
|POLY 3             |        P=0.192N         P=0.543N         P=0.227N         P=0.528N         P=0.282N                         | 
|POLY 1.5           |        P=0.194N         P=0.522N         P=0.231N         P=0.540N         P=0.281N                         | 
|POLY 6             |        P=0.192N         P=0.566N         P=0.221N         P=0.519N         P=0.283N                         | 
|LOGISTIC REGRESSION|        P=0.178N         P=0.562N         P=0.222N         P=0.560N         P=0.280N                         | 
|COCH-ARM / FISHERS |        P=0.190N         P=0.500N         P=0.247N         P=0.584N         P=0.293N                         | 
|ORDER RESTRICTED   |        P=0.122N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 21      
                     Statistical Analysis of Primary Tumors 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                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        0/50 (0%)        1/37 (3%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          1/31.33          0/29.15          1/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             0.0%             4.8%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/21 (0%)        0/13 (0%)        1/7 (14%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              229              ---              668 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.502          P=0.492          (e)              P=0.301          (e)                              | 
|POLY 3             |        P=0.548          P=0.489          (e)              P=0.409          (e)                              | 
|POLY 1.5           |        P=0.544          P=0.489          (e)              P=0.420          (e)                              | 
|POLY 6             |        P=0.555          P=0.494          (e)              P=0.395          (e)                              | 
|LOGISTIC REGRESSION|        P=0.584          P=0.607          (e)              P=0.301          (e)                              | 
|COCH-ARM / FISHERS |        P=0.566          P=0.500          (e)              P=0.425          (e)                              | 
|ORDER RESTRICTED   |        P=0.444          (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                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        0/50 (0%)        1/40 (3%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        2/35.19          1/31.15          0/36.65          1/32.49          0/28.81                          | 
|POLY-3 PERCENT (g) |        5.7%             3.2%             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    |        612              644              ---              523              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.165N         P=0.559N         P=0.194N         P=0.510N         P=0.265N                         | 
|POLY 3             |        P=0.192N         P=0.543N         P=0.227N         P=0.528N         P=0.282N                         | 
|POLY 1.5           |        P=0.194N         P=0.522N         P=0.231N         P=0.540N         P=0.281N                         | 
|POLY 6             |        P=0.192N         P=0.566N         P=0.221N         P=0.519N         P=0.283N                         | 
|LOGISTIC REGRESSION|        P=0.178N         P=0.562N         P=0.222N         P=0.560N         P=0.280N                         | 
|COCH-ARM / FISHERS |        P=0.190N         P=0.500N         P=0.247N         P=0.584N         P=0.293N                         | 
|ORDER RESTRICTED   |        P=0.122N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 22      
                     Statistical Analysis of Primary Tumors 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                                                                                                                           | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/49 (6%)        2/50 (4%)        1/50 (2%)        0/37 (0%)        1/32 (3%)                        | 
|POLY-3 RATE (b)    |        3/34.14          2/30.72          1/29.15          0/20.93          1/19.92                          | 
|POLY-3 PERCENT (g) |        8.8%             6.5%             3.4%             0.0%             5.0%                             | 
|TERMINAL (d)       |        0/18 (0%)        1/21 (5%)        1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        373              580              668 (T)          ---              404                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.253N         P=0.519N         P=0.366N         P=0.214N         P=0.519N                         | 
|POLY 3             |        P=0.215N         P=0.549N         P=0.362N         P=0.222N         P=0.511N                         | 
|POLY 1.5           |        P=0.201N         P=0.538N         P=0.336N         P=0.203N         P=0.502N                         | 
|POLY 6             |        P=0.239N         P=0.547N         P=0.398N         P=0.247N         P=0.522N                         | 
|LOGISTIC REGRESSION|        P=0.184N         P=0.482N         P=0.283N         P=0.145N         P=0.400N                         | 
|COCH-ARM / FISHERS |        P=0.184N         P=0.490N         P=0.301N         P=0.180N         P=0.482N                         | 
|ORDER RESTRICTED   |        P=0.295N         (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                                                                                                                           | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/49 (0%)        0/40 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        1/35.24          0/31.04          0/36.54          0/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        2.8%             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    |        599              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.234N         P=0.550N         P=0.466N         P=0.500N         P=0.550N                         | 
|POLY 3             |        P=0.251N         P=0.525N         P=0.493N         P=0.520N         P=0.540N                         | 
|POLY 1.5           |        P=0.254N         P=0.513N         P=0.497N         P=0.525N         P=0.539N                         | 
|POLY 6             |        P=0.248N         P=0.539N         P=0.487N         P=0.517N         P=0.542N                         | 
|LOGISTIC REGRESSION|        P=0.246N         P=0.515N         P=0.499N         P=0.536N         P=0.538N                         | 
|COCH-ARM / FISHERS |        P=0.251N         P=0.500N         P=0.505N         P=0.556N         P=0.543N                         | 
|ORDER RESTRICTED   |        P=0.126N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 23      
                     Statistical Analysis of Primary Tumors 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                                                                                                                           | 
|     Plasma Cell Tumor Malignant                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/48 (0%)        0/45 (0%)        0/47 (0%)        0/33 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/31.39          0/26.53          0/27.78          0/19.03          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        0/18 (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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Plasma Cell Tumor Malignant                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        2/44 (5%)        1/46 (2%)        0/36 (0%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.91          2/29.92          1/35.73          0/29.65          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             6.7%             2.8%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/17 (0%)        0/23 (0%)        0/19 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              441              182              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.259N         P=0.204          P=0.504          (e)              (e)                              | 
|POLY 3             |        P=0.270N         P=0.202          P=0.505          (e)              (e)                              | 
|POLY 1.5           |        P=0.267N         P=0.210          P=0.498          (e)              (e)                              | 
|POLY 6             |        P=0.273N         P=0.195          P=0.514          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.231N         P=0.207          P=0.397          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.263N         P=0.221          P=0.484          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.320N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 24      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangioma                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        1/50 (2%)        0/37 (0%)        0/32 (0%)                        | 
|POLY-3 RATE (b)    |        0/33.13          1/30.37          1/29.15          0/20.93          0/19.14                          | 
|POLY-3 PERCENT (g) |        0.0%             3.3%             3.4%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/19 (0%)        1/21 (5%)        1/13 (8%)        0/7 (0%)         0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              668 (T)          668 (T)          ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.556N         P=0.520          P=0.424          (e)              (e)                              | 
|POLY 3             |        P=0.481N         P=0.483          P=0.474          (e)              (e)                              | 
|POLY 1.5           |        P=0.465N         P=0.484          P=0.485          (e)              (e)                              | 
|POLY 6             |        P=0.502N         P=0.486          P=0.461          (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              P=0.520          P=0.424          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.434N         P=0.500          P=0.500          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.495N         (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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangioma                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        2/50 (4%)        2/40 (5%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          1/31.45          2/36.80          2/32.09          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             5.4%             6.2%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        1/24 (4%)        0/20 (0%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              560              631              646              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.559          P=0.441          P=0.281          P=0.250          (e)                              | 
|POLY 3             |        P=0.520          P=0.479          P=0.248          P=0.216          (e)                              | 
|POLY 1.5           |        P=0.513          P=0.489          P=0.243          P=0.209          (e)                              | 
|POLY 6             |        P=0.528          P=0.469          P=0.257          P=0.222          (e)                              | 
|LOGISTIC REGRESSION|        P=0.536          P=0.498          P=0.256          P=0.225          (e)                              | 
|COCH-ARM / FISHERS |        P=0.510          P=0.500          P=0.247          P=0.195          (e)                              | 
|ORDER RESTRICTED   |        P=0.306          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 25      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       6/50 (12%)       4/50 (8%)        2/37 (5%)        3/32 (9%)                        | 
|POLY-3 RATE (b)    |        7/36.30          6/31.83          4/30.11          2/21.18          3/20.40                          | 
|POLY-3 PERCENT (g) |        19.3%            18.9%            13.3%            9.4%             14.7%                            | 
|TERMINAL (d)       |        1/19 (5%)        3/21 (14%)       1/13 (8%)        1/7 (14%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        373              385              482              607              404                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.334N         P=0.536N         P=0.399N         P=0.315N         P=0.494N                         | 
|POLY 3             |        P=0.247N         P=0.604N         P=0.374N         P=0.274N         P=0.472N                         | 
|POLY 1.5           |        P=0.220N         P=0.582N         P=0.326N         P=0.232N         P=0.454N                         | 
|POLY 6             |        P=0.290N         P=0.610N         P=0.435N         P=0.332N         P=0.496N                         | 
|LOGISTIC REGRESSION|        P=0.204N         P=0.523N         P=0.274N         P=0.182N         P=0.384N                         | 
|COCH-ARM / FISHERS |        P=0.181N         P=0.500N         P=0.262N         P=0.173N         P=0.398N                         | 
|ORDER RESTRICTED   |        P=0.434N         (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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        1/50 (2%)        2/50 (4%)        1/40 (3%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        3/35.60          1/31.04          2/36.71          1/32.73          2/29.43                          | 
|POLY-3 PERCENT (g) |        8.4%             3.2%             5.5%             3.1%             6.8%                             | 
|TERMINAL (d)       |        1/20 (5%)        1/18 (6%)        1/24 (4%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        577              668 (T)          654              414              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.450N         P=0.385N         P=0.433N         P=0.335N         P=0.576N                         | 
|POLY 3             |        P=0.460N         P=0.354N         P=0.486N         P=0.334N         P=0.587N                         | 
|POLY 1.5           |        P=0.481N         P=0.329N         P=0.491N         P=0.346N         P=0.586N                         | 
|POLY 6             |        P=0.444N         P=0.385N         P=0.476N         P=0.327N         P=0.590N                         | 
|LOGISTIC REGRESSION|        P=0.497N         P=0.355N         P=0.475N         P=0.409N         P=0.586N                         | 
|COCH-ARM / FISHERS |        P=0.513N         P=0.309N         P=0.500N         P=0.397N         P=0.583N                         | 
|ORDER RESTRICTED   |        P=0.443N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 26      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma or Hemangioma                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/50 (14%)       7/50 (14%)       5/50 (10%)       2/37 (5%)        3/32 (9%)                        | 
|POLY-3 RATE (b)    |        7/36.30          7/31.83          5/30.11          2/21.18          3/20.40                          | 
|POLY-3 PERCENT (g) |        19.3%            22.0%            16.6%            9.4%             14.7%                            | 
|TERMINAL (d)       |        1/19 (5%)        4/21 (19%)       2/13 (15%)       1/7 (14%)        1/8 (13%)                        | 
|FIRST INCIDENCE    |        373              385              482              607              404                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.316N         P=0.579          P=0.541N         P=0.315N         P=0.494N                         | 
|POLY 3             |        P=0.218N         P=0.510          P=0.515N         P=0.274N         P=0.472N                         | 
|POLY 1.5           |        P=0.191N         P=0.532          P=0.460N         P=0.232N         P=0.454N                         | 
|POLY 6             |        P=0.262N         P=0.505          P=0.584N         P=0.332N         P=0.496N                         | 
|LOGISTIC REGRESSION|        P=0.175N         P=0.584          P=0.405N         P=0.182N         P=0.384N                         | 
|COCH-ARM / FISHERS |        P=0.150N         P=0.613N         P=0.380N         P=0.173N         P=0.398N                         | 
|ORDER RESTRICTED   |        P=0.387N         (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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma or Hemangioma                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/50 (6%)        2/50 (4%)        4/50 (8%)        3/40 (8%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        3/35.60          2/31.45          4/36.87          3/32.85          2/29.43                          | 
|POLY-3 PERCENT (g) |        8.4%             6.4%             10.9%            9.1%             6.8%                             | 
|TERMINAL (d)       |        1/20 (5%)        1/18 (6%)        2/24 (8%)        0/20 (0%)        1/19 (5%)                        | 
|FIRST INCIDENCE    |        577              560              631              414              482                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.476N         P=0.602N         P=0.585          P=0.643          P=0.576N                         | 
|POLY 3             |        P=0.514N         P=0.557N         P=0.519          P=0.627          P=0.587N                         | 
|POLY 1.5           |        P=0.533N         P=0.529N         P=0.512          P=0.611          P=0.586N                         | 
|POLY 6             |        P=0.500N         P=0.588N         P=0.534          P=0.637          P=0.590N                         | 
|LOGISTIC REGRESSION|        P=0.529N         P=0.550N         P=0.534          P=0.574          P=0.586N                         | 
|COCH-ARM / FISHERS |        P=0.547          P=0.500N         P=0.500          P=0.550          P=0.583N                         | 
|ORDER RESTRICTED   |        P=0.658N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 27      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/50 (2%)        1/50 (2%)        1/50 (2%)        2/40 (5%)        2/42 (5%)                        | 
|POLY-3 RATE (b)    |        1/34.96          1/31.46          1/36.80          2/32.09          2/28.81                          | 
|POLY-3 PERCENT (g) |        2.9%             3.2%             2.7%             6.2%             6.9%                             | 
|TERMINAL (d)       |        1/20 (5%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        2/19 (11%)                       | 
|FIRST INCIDENCE    |        668 (T)          556              631              641              668 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.225          P=0.720          P=0.719N         P=0.500          P=0.482                          | 
|POLY 3             |        P=0.201          P=0.738          P=0.750N         P=0.470          P=0.432                          | 
|POLY 1.5           |        P=0.193          P=0.749          P=0.755N         P=0.458          P=0.433                          | 
|POLY 6             |        P=0.206          P=0.726          P=0.741N         P=0.479          P=0.431                          | 
|LOGISTIC REGRESSION|        P=0.202          P=0.741          P=0.744N         P=0.489          P=0.482                          | 
|COCH-ARM / FISHERS |        P=0.180          P=0.753N         P=0.753N         P=0.416          P=0.434                          | 
|ORDER RESTRICTED   |        P=0.379          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 28      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/50 (12%)       9/50 (18%)       7/50 (14%)       4/37 (11%)       3/32 (9%)                        | 
|POLY-3 RATE (b)    |        6/35.21          9/33.67          7/32.43          4/21.95          3/19.77                          | 
|POLY-3 PERCENT (g) |        17.0%            26.7%            21.6%            18.2%            15.2%                            | 
|TERMINAL (d)       |        1/19 (5%)        2/21 (10%)       1/13 (8%)        0/7 (0%)         1/8 (13%)                        | 
|FIRST INCIDENCE    |        413              322              187              589              495                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.405N         P=0.269          P=0.370          P=0.527          P=0.625N                         | 
|POLY 3             |        P=0.358N         P=0.246          P=0.434          P=0.595          P=0.578N                         | 
|POLY 1.5           |        P=0.321N         P=0.242          P=0.461          P=0.630          P=0.559N                         | 
|POLY 6             |        P=0.411N         P=0.271          P=0.398          P=0.557          P=0.603N                         | 
|LOGISTIC REGRESSION|        P=0.273N         P=0.263          P=0.504          P=0.624N         P=0.533N                         | 
|COCH-ARM / FISHERS |        P=0.249N         P=0.288          P=0.500          P=0.571N         P=0.505N                         | 
|ORDER RESTRICTED   |        P=0.514N         (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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        19/50 (38%)      19/50 (38%)      20/50 (40%)      16/40 (40%)      17/42 (40%)                      | 
|POLY-3 RATE (b)    |        19/39.41         19/37.75         20/38.78         16/35.35         17/31.65                         | 
|POLY-3 PERCENT (g) |        48.2%            50.3%            51.6%            45.3%            53.7%                            | 
|TERMINAL (d)       |        8/20 (40%)       8/18 (44%)       15/24 (63%)      8/20 (40%)       11/19 (58%)                      | 
|FIRST INCIDENCE    |        352              341              425              359              325                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.395N         P=0.362          P=0.447N         P=0.415N         P=0.552                          | 
|POLY 3             |        P=0.463          P=0.517          P=0.471          P=0.491N         P=0.409                          | 
|POLY 1.5           |        P=0.446          P=0.561          P=0.487          P=0.525N         P=0.439                          | 
|POLY 6             |        P=0.458          P=0.460          P=0.454          P=0.479N         P=0.363                          | 
|LOGISTIC REGRESSION|        P=0.475          P=0.534          P=0.552          P=0.578N         P=0.464                          | 
|COCH-ARM / FISHERS |        P=0.411          P=0.582N         P=0.500          P=0.509          P=0.488                          | 
|ORDER RESTRICTED   |        P=0.555          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 29      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Osteosarcoma or Osteoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Osteosarcoma or Osteoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/50 (0%)        1/40 (3%)        0/42 (0%)                        | 
|POLY-3 RATE (b)    |        0/34.96          2/31.79          0/36.65          1/31.97          0/28.81                          | 
|POLY-3 PERCENT (g) |        0.0%             6.3%             0.0%             3.1%             0.0%                             | 
|TERMINAL (d)       |        0/20 (0%)        0/18 (0%)        0/24 (0%)        1/20 (5%)        0/19 (0%)                        | 
|FIRST INCIDENCE    |        ---              565              ---              668 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.444N         P=0.160          (e)              P=0.500          (e)                              | 
|POLY 3             |        P=0.504N         P=0.215          (e)              P=0.482          (e)                              | 
|POLY 1.5           |        P=0.493N         P=0.226          (e)              P=0.476          (e)                              | 
|POLY 6             |        P=0.516N         P=0.206          (e)              P=0.487          (e)                              | 
|LOGISTIC REGRESSION|        P=0.461N         P=0.231          (e)              P=0.500          (e)                              | 
|COCH-ARM / FISHERS |        P=0.471N         P=0.247          (e)              P=0.444          (e)                              | 
|ORDER RESTRICTED   |        P=0.334N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 30      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        27/50 (54%)      23/50 (46%)      27/50 (54%)      18/37 (49%)      16/32 (50%)                      | 
|POLY-3 RATE (b)    |        27/38.82         23/35.83         27/35.35         18/25.42         16/24.75                         | 
|POLY-3 PERCENT (g) |        69.6%            64.2%            76.4%            70.8%            64.6%                            | 
|TERMINAL (d)       |        11/19 (58%)      12/21 (57%)      11/13 (85%)      7/7 (100%)       5/8 (63%)                        | 
|FIRST INCIDENCE    |        413              229              322              167              229                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.113          P=0.311N         P=0.146          P=0.140          P=0.359                          | 
|POLY 3             |        P=0.451N         P=0.398N         P=0.330          P=0.573          P=0.444N                         | 
|POLY 1.5           |        P=0.443N         P=0.378N         P=0.430          P=0.543N         P=0.463N                         | 
|POLY 6             |        P=0.542N         P=0.394N         P=0.233          P=0.425          P=0.476N                         | 
|LOGISTIC REGRESSION|        P=0.469          P=0.413N         P=0.355          P=0.581          P=0.577N                         | 
|COCH-ARM / FISHERS |        P=0.438N         P=0.274N         P=0.579N         P=0.391N         P=0.449N                         | 
|ORDER RESTRICTED   |        P=0.545N         (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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        17/50 (34%)      17/50 (34%)      23/50 (46%)      14/40 (35%)      16/42 (38%)                      | 
|POLY-3 RATE (b)    |        17/38.06         17/32.74         23/39.33         14/34.17         16/31.28                         | 
|POLY-3 PERCENT (g) |        44.7%            51.9%            58.5%            41.0%            51.2%                            | 
|TERMINAL (d)       |        7/20 (35%)       11/18 (61%)      14/24 (58%)      8/20 (40%)       10/19 (53%)                      | 
|FIRST INCIDENCE    |        510              560              432              359              453                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.376N         P=0.337          P=0.354          P=0.389N         P=0.487                          | 
|POLY 3             |        P=0.492N         P=0.349          P=0.153          P=0.468N         P=0.380                          | 
|POLY 1.5           |        P=0.520          P=0.470          P=0.151          P=0.494N         P=0.394                          | 
|POLY 6             |        P=0.480N         P=0.222          P=0.162          P=0.480N         P=0.353                          | 
|LOGISTIC REGRESSION|        P=0.512N         P=0.347          P=0.179          P=0.484N         P=0.391                          | 
|COCH-ARM / FISHERS |        P=0.418          P=0.583N         P=0.154          P=0.548          P=0.424                          | 
|ORDER RESTRICTED   |        P=0.504          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 31      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        19/50 (38%)      27/50 (54%)      20/50 (40%)      20/37 (54%)      17/32 (53%)                      | 
|POLY-3 RATE (b)    |        19/39.22         27/39.79         20/36.28         20/27.27         17/24.12                         | 
|POLY-3 PERCENT (g) |        48.4%            67.9%            55.1%            73.3%            70.5%                            | 
|TERMINAL (d)       |        5/19 (26%)       10/21 (48%)      6/13 (46%)       4/7 (57%)        5/8 (63%)                        | 
|FIRST INCIDENCE    |        373              157              187              341              376                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.026 *        P=0.117          P=0.229          P=0.019 *        P=0.063                          | 
|POLY 3             |        P=0.036 *        P=0.056          P=0.358          P=0.030 *        P=0.064                          | 
|POLY 1.5           |        P=0.044 *        P=0.050          P=0.414          P=0.041 *        P=0.066                          | 
|POLY 6             |        P=0.031 *        P=0.078          P=0.293          P=0.027 *        P=0.066                          | 
|LOGISTIC REGRESSION|        P=0.076          P=0.058          P=0.443          P=0.054          P=0.084                          | 
|COCH-ARM / FISHERS |        P=0.120          P=0.080          P=0.500          P=0.102          P=0.132                          | 
|ORDER RESTRICTED   |        P=0.049 *        (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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        30/50 (60%)      28/50 (56%)      31/50 (62%)      25/40 (63%)      27/42 (64%)                      | 
|POLY-3 RATE (b)    |        30/40.73         28/39.76         31/41.49         25/37.56         27/33.48                         | 
|POLY-3 PERCENT (g) |        73.7%            70.4%            74.7%            66.6%            80.6%                            | 
|TERMINAL (d)       |        15/20 (75%)      12/18 (67%)      19/24 (79%)      11/20 (55%)      17/19 (90%)                      | 
|FIRST INCIDENCE    |        352              341              182              359              325                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.419N         P=0.382          P=0.361N         P=0.332N         P=0.523                          | 
|POLY 3             |        P=0.374          P=0.468N         P=0.560          P=0.323N         P=0.318                          | 
|POLY 1.5           |        P=0.330          P=0.418N         P=0.556          P=0.410N         P=0.353                          | 
|POLY 6             |        P=0.387          P=0.542N         P=0.559          P=0.278N         P=0.254                          | 
|LOGISTIC REGRESSION|        P=0.362          P=0.543N         P=0.566          P=0.498N         P=0.363                          | 
|COCH-ARM / FISHERS |        P=0.274          P=0.420N         P=0.500          P=0.491          P=0.419                          | 
|ORDER RESTRICTED   |        P=0.307          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/08/03                           EXPERIMENT: 99022 TEST: 02                                            Page 32      
                     Statistical Analysis of Primary Tumors 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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        35/50 (70%)      35/50 (70%)      34/50 (68%)      25/37 (68%)      26/32 (81%)                      | 
|POLY-3 RATE (b)    |        35/42.09         35/41.72         34/39.18         25/28.41         26/27.62                         | 
|POLY-3 PERCENT (g) |        83.2%            83.9%            86.8%            88.0%            94.1%                            | 
|TERMINAL (d)       |        14/19 (74%)      15/21 (71%)      12/13 (92%)      7/7 (100%)       8/8 (100%)                       | 
|FIRST INCIDENCE    |        373              157              187              167              229                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.019 *        P=0.536          P=0.163          P=0.077          P=0.063                          | 
|POLY 3             |        P=0.070          P=0.585          P=0.434          P=0.404          P=0.137                          | 
|POLY 1.5           |        P=0.087          P=0.541          P=0.551          P=0.525          P=0.110                          | 
|POLY 6             |        P=0.049 *        P=0.589N         P=0.302          P=0.291          P=0.160                          | 
|LOGISTIC REGRESSION|        P=0.079          P=0.400          P=0.487          P=0.455          P=0.062                          | 
|COCH-ARM / FISHERS |        P=0.206          P=0.586N         P=0.500N         P=0.495N         P=0.190                          | 
|ORDER RESTRICTED   |        P=0.130          (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                         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        35/50 (70%)      33/50 (66%)      38/50 (76%)      31/40 (78%)      33/42 (79%)                      | 
|POLY-3 RATE (b)    |        35/41.62         33/39.81         38/42.65         31/38.17         33/35.51                         | 
|POLY-3 PERCENT (g) |        84.1%            82.9%            89.1%            81.2%            92.9%                            | 
|TERMINAL (d)       |        16/20 (80%)      16/18 (89%)      23/24 (96%)      16/20 (80%)      19/19 (100%)                     | 
|FIRST INCIDENCE    |        352              341              182              359              325                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.515          P=0.343          P=0.435N         P=0.402N         P=0.399                          | 
|POLY 3             |        P=0.207          P=0.568N         P=0.347          P=0.481N         P=0.167                          | 
|POLY 1.5           |        P=0.140          P=0.447N         P=0.357          P=0.586N         P=0.175                          | 
|POLY 6             |        P=0.257          P=0.538          P=0.324          P=0.451N         P=0.141                          | 
|LOGISTIC REGRESSION|        P=0.158          P=0.595          P=0.364          P=0.575          P=0.162                          | 
|COCH-ARM / FISHERS |        P=0.101          P=0.415N         P=0.326          P=0.289          P=0.245                          | 
|ORDER RESTRICTED   |        P=0.150          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
                                                                                                                                   
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).