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TDMS Study 88122-06 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          ELMIRON                                        DATE: 06/12/01       
EXPERIMENT: 88122 TEST: 06                                                                                     TIME: 09:18:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: C88122       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 37319-17-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                              FINAL#1                                                               
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          ELMIRON                                        DATE: 06/12/01       
EXPERIMENT: 88122 TEST: 06                                                                                     TIME: 09:18:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: C88122       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 37319-17-8      
Rats(FISCHER 344)                                                                                                                   
-----------------------------                                                                                                       
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                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Islets, Pancreatic                                                                 
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Nose                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Salivary Glands                                                                    
                                                 Testes                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          ELMIRON                                        DATE: 06/12/01       
EXPERIMENT: 88122 TEST: 06                                                                                     TIME: 09:18:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: C88122       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 37319-17-8      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                     ELMIRON                                                                                      
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
All Organs                             Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
===============================================================                                                                     
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                      ELMIRON              
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   7/50 (14%)   3/50 (6%)    8/50 (16%)  |2/50 (4%)    1/50 (2%)    0/50 (0%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     7/41.59      7/41.97      3/39.89      8/40.29     |2/41.96      1/42.89      0/41.46      3/39.33      | 
|POLY-3 PERCENT (g) |     16.8%        16.7%        7.5%         19.9%       |4.8%         2.3%         0.0%         7.6%         | 
|TERMINAL (d)       |     4/26 (15%)   6/29 (21%)   3/25 (12%)   7/28 (25%)  |1/30 (3%)    1/31 (3%)    0/28 (0%)    2/27 (7%)    | 
|FIRST INCIDENCE    |     640          713          727 (T)      660         |722          728 (T)      ---          727          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.425      P=0.537N     P=0.191N     P=0.544     |P=0.222      P=0.496N     P=0.258N     P=0.456      | 
|POLY 3             |     P=0.383      P=0.608N     P=0.172N     P=0.473     |P=0.238      P=0.492N     P=0.240N     P=0.470      | 
|POLY 1.5           |     P=0.382      P=0.612      P=0.162N     P=0.468     |P=0.241      P=0.496N     P=0.239N     P=0.474      | 
|POLY 6             |     P=0.391      P=0.593N     P=0.187N     P=0.488     |P=0.235      P=0.488N     P=0.240N     P=0.469      | 
|LOGISTIC REGRESSION|     P=0.389      P=0.569N     P=0.193N     P=0.498     |P=0.220      P=0.486N     P=0.247N     P=0.458      | 
|COCH-ARM / FISHERS |     P=0.409      P=0.613N     P=0.159N     P=0.500     |P=0.257      P=0.500N     P=0.247N     P=0.500      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Malignant                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    3/50 (6%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/41.22      0/41.91      3/40.86      1/40.04     |1/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         7.3%         2.5%        |2.4%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    0/29 (0%)    1/25 (4%)    1/28 (4%)   |1/30 (3%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      ---          419          727 (T)     |728 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.564      P=0.478N     P=0.292      P=0.746N    |P=0.490N     P=0.493N     P=0.514N     P=0.521N     | 
|POLY 3             |     P=0.544      P=0.497N     P=0.301      P=0.755     |P=0.472N     P=0.496N     P=0.502N     P=0.513N     | 
|POLY 1.5           |     P=0.544      P=0.500N     P=0.306      P=0.753     |P=0.471N     P=0.498N     P=0.502N     P=0.511N     | 
|POLY 6             |     P=0.547      P=0.491N     P=0.294      P=0.759     |P=0.474N     P=0.493N     P=0.503N     P=0.513N     | 
|LOGISTIC REGRESSION|     P=0.566      (e)          P=0.302      P=0.746N    |P=0.490N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.564      P=0.500N     P=0.309      P=0.753N    |P=0.471N     P=0.500N     P=0.500N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   7/50 (14%)   6/50 (12%)   9/50 (18%)  |3/50 (6%)    1/50 (2%)    0/50 (0%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     7/41.59      7/41.97      6/40.86      9/40.29     |3/41.96      1/42.89      0/41.46      3/39.33      | 
|POLY-3 PERCENT (g) |     16.8%        16.7%        14.7%        22.3%       |7.2%         2.3%         0.0%         7.6%         | 
|TERMINAL (d)       |     4/26 (15%)   6/29 (21%)   4/25 (16%)   8/28 (29%)  |2/30 (7%)    1/31 (3%)    0/28 (0%)    2/27 (7%)    | 
|FIRST INCIDENCE    |     640          713          419          660         |722          728 (T)      ---          727          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.321      P=0.537N     P=0.549N     P=0.439     |P=0.357      P=0.300N     P=0.137N     P=0.616      | 
|POLY 3             |     P=0.276      P=0.608N     P=0.514N     P=0.363     |P=0.378      P=0.297N     P=0.120N     P=0.633      | 
|POLY 1.5           |     P=0.277      P=0.612      P=0.501N     P=0.360     |P=0.382      P=0.301N     P=0.120N     P=0.636      | 
|POLY 6             |     P=0.283      P=0.593N     P=0.536N     P=0.377     |P=0.374      P=0.292N     P=0.121N     P=0.632      | 
|LOGISTIC REGRESSION|     P=0.283      P=0.569N     P=0.522N     P=0.388     |P=0.357      P=0.291N     P=0.129N     P=0.622      | 
|COCH-ARM / FISHERS |     P=0.307      P=0.613N     P=0.500N     P=0.393     |P=0.402      P=0.309N     P=0.121N     P=0.661N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |3/50 (6%)    0/50 (0%)    0/50 (0%)    4/49 (8%)    | 
|POLY-3 RATE (b)    |     1/41.22      1/41.91      1/39.89      2/40.07     |3/42.38      0/42.89      0/41.46      4/38.41      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         2.5%         5.0%        |7.1%         0.0%         0.0%         10.4%        | 
|TERMINAL (d)       |     1/26 (4%)    1/29 (3%)    1/25 (4%)    1/28 (4%)   |2/30 (7%)    0/31 (0%)    0/28 (0%)    3/26 (12%)   | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      720         |601          ---          ---          706          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.369      P=0.738N     P=0.754      P=0.513     |P=0.098      P=0.118N     P=0.129N     P=0.436      | 
|POLY 3             |     P=0.349      P=0.757N     P=0.754      P=0.490     |P=0.108      P=0.116N     P=0.122N     P=0.446      | 
|POLY 1.5           |     P=0.348      P=0.760N     P=0.758      P=0.487     |P=0.110      P=0.117N     P=0.121N     P=0.453      | 
|POLY 6             |     P=0.352      P=0.752N     P=0.747      P=0.498     |P=0.105      P=0.115N     P=0.124N     P=0.442      | 
|LOGISTIC REGRESSION|     P=0.347      P=0.738N     P=0.754      P=0.496     |P=0.103      P=0.119N     P=0.122N     P=0.451      | 
|COCH-ARM / FISHERS |     P=0.361      P=0.753N     P=0.753N     P=0.500     |P=0.124      P=0.121N     P=0.121N     P=0.489      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |3/50 (6%)    0/50 (0%)    0/50 (0%)    4/49 (8%)    | 
|POLY-3 RATE (b)    |     2/41.94      1/41.91      1/39.89      2/40.07     |3/42.38      0/42.89      0/41.46      4/38.41      | 
|POLY-3 PERCENT (g) |     4.8%         2.4%         2.5%         5.0%        |7.1%         0.0%         0.0%         10.4%        | 
|TERMINAL (d)       |     1/26 (4%)    1/29 (3%)    1/25 (4%)    1/28 (4%)   |2/30 (7%)    0/31 (0%)    0/28 (0%)    3/26 (12%)   | 
|FIRST INCIDENCE    |     475          727 (T)      727 (T)      720         |601          ---          ---          706          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.523      P=0.480N     P=0.511N     P=0.691     |P=0.098      P=0.118N     P=0.129N     P=0.436      | 
|POLY 3             |     P=0.507      P=0.500N     P=0.517N     P=0.678     |P=0.108      P=0.116N     P=0.122N     P=0.446      | 
|POLY 1.5           |     P=0.508      P=0.503N     P=0.508N     P=0.677     |P=0.110      P=0.117N     P=0.121N     P=0.453      | 
|POLY 6             |     P=0.508      P=0.494N     P=0.531N     P=0.684     |P=0.105      P=0.115N     P=0.124N     P=0.442      | 
|LOGISTIC REGRESSION|     P=0.513      P=0.498N     P=0.502N     P=0.693     |P=0.103      P=0.119N     P=0.122N     P=0.451      | 
|COCH-ARM / FISHERS |     P=0.524      P=0.500N     P=0.500N     P=0.691N    |P=0.124      P=0.121N     P=0.121N     P=0.489      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/41.22      1/42.00      1/40.49      0/40.04     |0/41.94      1/42.89      2/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         2.5%         0.0%        |0.0%         2.3%         4.8%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    0/29 (0%)    0/25 (0%)    0/28 (0%)   |0/30 (0%)    1/31 (3%)    2/28 (7%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      705          533          ---         |---          728 (T)      728 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.330N     P=0.735N     P=0.758      P=0.485N    |P=0.550N     P=0.507      P=0.223      (e)          | 
|POLY 3             |     P=0.332N     P=0.757N     P=0.757      P=0.506N    |P=0.544N     P=0.504      P=0.234      (e)          | 
|POLY 1.5           |     P=0.333N     P=0.760N     P=0.760      P=0.507N    |P=0.540N     P=0.502      P=0.235      (e)          | 
|POLY 6             |     P=0.330N     P=0.751N     P=0.752      P=0.502N    |P=0.545N     P=0.507      P=0.233      (e)          | 
|LOGISTIC REGRESSION|     P=0.321N     P=0.752N     P=0.759      (e)         |(e)          P=0.507      P=0.223      (e)          | 
|COCH-ARM / FISHERS |     P=0.323N     P=0.753N     P=0.753N     P=0.500N    |P=0.517N     P=0.500      P=0.247      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/41.22      2/42.00      1/40.49      0/40.04     |0/41.94      1/42.89      2/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     2.4%         4.8%         2.5%         0.0%        |0.0%         2.3%         4.8%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    1/29 (3%)    0/25 (0%)    0/28 (0%)   |0/30 (0%)    1/31 (3%)    2/28 (7%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      705          533          ---         |---          728 (T)      728 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.239N     P=0.539      P=0.758      P=0.485N    |P=0.550N     P=0.507      P=0.223      (e)          | 
|POLY 3             |     P=0.242N     P=0.507      P=0.757      P=0.506N    |P=0.544N     P=0.504      P=0.234      (e)          | 
|POLY 1.5           |     P=0.244N     P=0.501      P=0.760      P=0.507N    |P=0.540N     P=0.502      P=0.235      (e)          | 
|POLY 6             |     P=0.238N     P=0.516      P=0.752      P=0.502N    |P=0.545N     P=0.507      P=0.233      (e)          | 
|LOGISTIC REGRESSION|     P=0.238N     P=0.521      P=0.759      (e)         |(e)          P=0.507      P=0.223      (e)          | 
|COCH-ARM / FISHERS |     P=0.235N     P=0.500      P=0.753N     P=0.500N    |P=0.517N     P=0.500      P=0.247      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/41.22      1/42.41      1/40.05      2/40.04     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         2.5%         5.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/26 (0%)    0/29 (0%)    0/25 (0%)    2/28 (7%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     ---          577          686          727 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.200      P=0.505      P=0.475      P=0.254     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.183      P=0.506      P=0.494      P=0.230     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.183      P=0.502      P=0.498      P=0.229     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.186      P=0.512      P=0.489      P=0.235     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.187      P=0.509      P=0.496      P=0.254     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.193      P=0.500      P=0.500      P=0.247     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/41.38      0/41.91      0/39.89      1/40.04     |0/41.94      1/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         0.0%         2.5%        |0.0%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    0/29 (0%)    0/25 (0%)    1/28 (4%)   |0/30 (0%)    1/31 (3%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     685          ---          ---          727 (T)     |---          728 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.642N     P=0.225N     P=0.258N     P=0.486N    |P=0.605N     P=0.507      (e)          (e)          | 
|POLY 3             |     P=0.651N     P=0.234N     P=0.245N     P=0.512N    |P=0.585N     P=0.504      (e)          (e)          | 
|POLY 1.5           |     P=0.649N     P=0.237N     P=0.240N     P=0.513N    |P=0.586N     P=0.502      (e)          (e)          | 
|POLY 6             |     P=0.653N     P=0.229N     P=0.253N     P=0.506N    |P=0.584N     P=0.507      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.652N     P=0.231N     P=0.250N     P=0.503N    |(e)          P=0.507      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.646N     P=0.247N     P=0.247N     P=0.500N    |P=0.585N     P=0.500      (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    3/50 (6%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/41.38      1/42.41      1/40.05      3/40.04     |0/41.94      1/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     4.8%         2.4%         2.5%         7.5%        |0.0%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    0/29 (0%)    0/25 (0%)    3/28 (11%)  |0/30 (0%)    1/31 (3%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     685          577          686          727 (T)     |---          728 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.290      P=0.481N     P=0.533N     P=0.524     |P=0.605N     P=0.507      (e)          (e)          | 
|POLY 3             |     P=0.266      P=0.491N     P=0.511N     P=0.485     |P=0.585N     P=0.504      (e)          (e)          | 
|POLY 1.5           |     P=0.268      P=0.498N     P=0.504N     P=0.483     |P=0.586N     P=0.502      (e)          (e)          | 
|POLY 6             |     P=0.266      P=0.481N     P=0.522N     P=0.493     |P=0.584N     P=0.507      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.269      P=0.500N     P=0.515N     P=0.500     |(e)          P=0.507      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.281      P=0.500N     P=0.500N     P=0.500     |P=0.585N     P=0.500      (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     0/41.22      0/41.91      0/39.89      0/40.04     |1/42.02      1/43.09      1/41.46      3/39.52      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.4%         2.3%         2.4%         7.6%         | 
|TERMINAL (d)       |     0/26 (0%)    0/29 (0%)    0/25 (0%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    1/28 (4%)    2/27 (7%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |707          678          728 (T)      678          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.127      P=0.748N     P=0.746      P=0.271      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.140      P=0.755N     P=0.758      P=0.283      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.142      P=0.758N     P=0.758      P=0.285      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.138      P=0.752N     P=0.757      P=0.283      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.135      P=0.760N     P=0.759      P=0.281      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.156      P=0.753N     P=0.753N     P=0.309      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    2/50 (4%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     1/41.22      0/41.91      0/39.89      0/40.04     |1/42.02      1/43.09      2/41.46      4/39.52      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         0.0%         0.0%        |2.4%         2.3%         4.8%         10.1%        | 
|TERMINAL (d)       |     1/26 (4%)    0/29 (0%)    0/25 (0%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    2/28 (7%)    3/27 (11%)   | 
|FIRST INCIDENCE    |     727 (T)      ---          ---          ---         |707          678          728 (T)      678          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.467N     P=0.478N     P=0.508N     P=0.485N    |P=0.055      P=0.748N     P=0.477      P=0.153      | 
|POLY 3             |     P=0.472N     P=0.497N     P=0.507N     P=0.506N    |P=0.061      P=0.755N     P=0.495      P=0.159      | 
|POLY 1.5           |     P=0.470N     P=0.500N     P=0.502N     P=0.507N    |P=0.063      P=0.758N     P=0.496      P=0.162      | 
|POLY 6             |     P=0.476N     P=0.491N     P=0.513N     P=0.502N    |P=0.060      P=0.752N     P=0.493      P=0.159      | 
|LOGISTIC REGRESSION|     P=0.467N     (e)          (e)          (e)         |P=0.059      P=0.760N     P=0.490      P=0.159      | 
|COCH-ARM / FISHERS |     P=0.471N     P=0.500N     P=0.500N     P=0.500N    |P=0.074      P=0.753N     P=0.500      P=0.181      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    3/50 (6%)    5/50 (10%)  |15/50 (30%)  23/50 (46%)  24/50 (48%)  21/50 (42%)  | 
|POLY-3 RATE (b)    |     2/42.52      1/41.91      3/40.40      5/40.04     |15/42.95     23/44.70     24/42.93     21/40.67     | 
|POLY-3 PERCENT (g) |     4.7%         2.4%         7.4%         12.5%       |34.9%        51.5%        55.9%        51.6%        | 
|TERMINAL (d)       |     0/26 (0%)    1/29 (3%)    2/25 (8%)    5/28 (18%)  |11/30 (37%)  16/31 (52%)  17/28 (61%)  14/27 (52%)  | 
|FIRST INCIDENCE    |     503          727 (T)      574          727 (T)     |621          474          474          588          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.077      P=0.495N     P=0.491      P=0.227     |P=0.171      P=0.111      P=0.036 *    P=0.093      | 
|POLY 3             |     P=0.063      P=0.505N     P=0.477      P=0.191     |P=0.186      P=0.085      P=0.036 *    P=0.088      | 
|POLY 1.5           |     P=0.064      P=0.506N     P=0.490      P=0.194     |P=0.205      P=0.078      P=0.039 *    P=0.095      | 
|POLY 6             |     P=0.062      P=0.501N     P=0.459      P=0.192     |P=0.179      P=0.094      P=0.032 *    P=0.087      | 
|LOGISTIC REGRESSION|     P=0.070      P=0.486N     P=0.481      P=0.212     |P=0.192      P=0.082      P=0.038 *    P=0.088      | 
|COCH-ARM / FISHERS |     P=0.074      P=0.500N     P=0.500      P=0.218     |P=0.322      P=0.074      P=0.050      P=0.149      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    1/50 (2%)    3/50 (6%)    5/50 (10%)  |15/50 (30%)  23/50 (46%)  24/50 (48%)  21/50 (42%)  | 
|POLY-3 RATE (b)    |     4/42.52      1/41.91      3/40.40      5/40.04     |15/42.95     23/44.70     24/42.93     21/40.67     | 
|POLY-3 PERCENT (g) |     9.4%         2.4%         7.4%         12.5%       |34.9%        51.5%        55.9%        51.6%        | 
|TERMINAL (d)       |     2/26 (8%)    1/29 (3%)    2/25 (8%)    5/28 (18%)  |11/30 (37%)  16/31 (52%)  17/28 (61%)  14/27 (52%)  | 
|FIRST INCIDENCE    |     503          727 (T)      574          727 (T)     |621          474          474          588          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.218      P=0.167N     P=0.513N     P=0.520     |P=0.171      P=0.111      P=0.036 *    P=0.093      | 
|POLY 3             |     P=0.189      P=0.182N     P=0.528N     P=0.462     |P=0.186      P=0.085      P=0.036 *    P=0.088      | 
|POLY 1.5           |     P=0.193      P=0.184N     P=0.512N     P=0.466     |P=0.205      P=0.078      P=0.039 *    P=0.095      | 
|POLY 6             |     P=0.188      P=0.178N     P=0.549N     P=0.466     |P=0.179      P=0.094      P=0.032 *    P=0.087      | 
|LOGISTIC REGRESSION|     P=0.200      P=0.177N     P=0.502N     P=0.486     |P=0.192      P=0.082      P=0.038 *    P=0.088      | 
|COCH-ARM / FISHERS |     P=0.212      P=0.181N     P=0.500N     P=0.500     |P=0.322      P=0.074      P=0.050      P=0.149      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    1/50 (2%)    3/50 (6%)    5/50 (10%)  |16/50 (32%)  24/50 (48%)  24/50 (48%)  24/50 (48%)  | 
|POLY-3 RATE (b)    |     4/42.52      1/41.91      3/40.40      5/40.04     |16/43.03     24/44.89     24/42.93     24/40.86     | 
|POLY-3 PERCENT (g) |     9.4%         2.4%         7.4%         12.5%       |37.2%        53.5%        55.9%        58.7%        | 
|TERMINAL (d)       |     2/26 (8%)    1/29 (3%)    2/25 (8%)    5/28 (18%)  |11/30 (37%)  16/31 (52%)  17/28 (61%)  16/27 (59%)  | 
|FIRST INCIDENCE    |     503          727 (T)      574          727 (T)     |621          474          474          588          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.218      P=0.167N     P=0.513N     P=0.520     |P=0.079      P=0.121      P=0.058      P=0.045 *    | 
|POLY 3             |     P=0.189      P=0.182N     P=0.528N     P=0.462     |P=0.077      P=0.089      P=0.058      P=0.034 *    | 
|POLY 1.5           |     P=0.193      P=0.184N     P=0.512N     P=0.466     |P=0.089      P=0.081      P=0.063      P=0.039 *    | 
|POLY 6             |     P=0.188      P=0.178N     P=0.549N     P=0.466     |P=0.072      P=0.101      P=0.052      P=0.034 *    | 
|LOGISTIC REGRESSION|     P=0.200      P=0.177N     P=0.502N     P=0.486     |P=0.080      P=0.084      P=0.060      P=0.036 *    | 
|COCH-ARM / FISHERS |     P=0.212      P=0.181N     P=0.500N     P=0.500     |P=0.174      P=0.076      P=0.076      P=0.076      | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     19/50 (38%)  18/50 (36%)  18/50 (36%)  13/50 (26%) |21/50 (42%)  21/50 (42%)  26/50 (52%)  19/50 (38%)  | 
|POLY-3 RATE (b)    |     19/44.60     18/44.62     18/42.45     13/41.07    |21/45.02     21/44.26     26/44.55     19/41.27     | 
|POLY-3 PERCENT (g) |     42.6%        40.3%        42.4%        31.7%       |46.7%        47.5%        58.4%        46.0%        | 
|TERMINAL (d)       |     12/26 (46%)  10/29 (35%)  11/25 (44%)  8/28 (29%)  |9/30 (30%)   16/31 (52%)  14/28 (50%)  11/27 (41%)  | 
|FIRST INCIDENCE    |     503          313          462          629         |462          526          474          525          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.124N     P=0.397N     P=0.568N     P=0.131N    |P=0.540      P=0.533N     P=0.202      P=0.560N     | 
|POLY 3             |     P=0.170N     P=0.499N     P=0.580N     P=0.203N    |P=0.510N     P=0.555      P=0.181      P=0.564N     | 
|POLY 1.5           |     P=0.159N     P=0.507N     P=0.536N     P=0.193N    |P=0.481N     P=0.567      P=0.188      P=0.535N     | 
|POLY 6             |     P=0.170N     P=0.484N     P=0.546      P=0.199N    |P=0.528N     P=0.530      P=0.170      P=0.587      | 
|LOGISTIC REGRESSION|     P=0.125N     P=0.501N     P=0.509N     P=0.161N    |P=0.461N     P=0.560N     P=0.198      P=0.504N     | 
|COCH-ARM / FISHERS |     P=0.107N     P=0.500N     P=0.500N     P=0.142N    |P=0.345N     P=0.580N     P=0.212      P=0.419N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     20/50 (40%)  18/50 (36%)  18/50 (36%)  13/50 (26%) |21/50 (42%)  21/50 (42%)  26/50 (52%)  19/50 (38%)  | 
|POLY-3 RATE (b)    |     20/44.92     18/44.62     18/42.45     13/41.07    |21/45.02     21/44.26     26/44.55     19/41.27     | 
|POLY-3 PERCENT (g) |     44.5%        40.3%        42.4%        31.7%       |46.7%        47.5%        58.4%        46.0%        | 
|TERMINAL (d)       |     12/26 (46%)  10/29 (35%)  11/25 (44%)  8/28 (29%)  |9/30 (30%)   16/31 (52%)  14/28 (50%)  11/27 (41%)  | 
|FIRST INCIDENCE    |     503          313          462          629         |462          526          474          525          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.102N     P=0.327N     P=0.496N     P=0.097N    |P=0.540      P=0.533N     P=0.202      P=0.560N     | 
|POLY 3             |     P=0.141N     P=0.425N     P=0.506N     P=0.155N    |P=0.510N     P=0.555      P=0.181      P=0.564N     | 
|POLY 1.5           |     P=0.129N     P=0.429N     P=0.458N     P=0.144N    |P=0.481N     P=0.567      P=0.188      P=0.535N     | 
|POLY 6             |     P=0.143N     P=0.418N     P=0.569N     P=0.156N    |P=0.528N     P=0.530      P=0.170      P=0.587      | 
|LOGISTIC REGRESSION|     P=0.099N     P=0.419N     P=0.426N     P=0.116N    |P=0.461N     P=0.560N     P=0.198      P=0.504N     | 
|COCH-ARM / FISHERS |     P=0.085N     P=0.418N     P=0.418N     P=0.101N    |P=0.345N     P=0.580N     P=0.212      P=0.419N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    1/49 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/41.37      2/42.42      1/39.36      1/40.12     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     2.4%         4.7%         2.5%         2.5%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/26 (0%)    0/29 (0%)    0/25 (0%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     686          645          630          707         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.544N     P=0.528      P=0.741      P=0.760     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.549N     P=0.509      P=0.750      P=0.754     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.550N     P=0.502      P=0.754      P=0.752     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.545N     P=0.520      P=0.744      P=0.759     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.542N     P=0.500      P=0.758      P=0.757     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.538N     P=0.500      P=0.747      P=0.753N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    3/50 (6%)    4/50 (8%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/41.22      3/42.14      4/40.53      1/40.18     |1/41.94      0/42.89      1/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     9.7%         7.1%         9.9%         2.5%        |2.4%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     4/26 (15%)   2/29 (7%)    1/25 (4%)    0/28 (0%)   |1/30 (3%)    0/31 (0%)    1/28 (4%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      668          630          691         |728 (T)      ---          728 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.157N     P=0.442N     P=0.605      P=0.163N    |P=0.486N     P=0.493N     P=0.747      P=0.521N     | 
|POLY 3             |     P=0.165N     P=0.488N     P=0.635      P=0.185N    |P=0.476N     P=0.496N     P=0.758      P=0.513N     | 
|POLY 1.5           |     P=0.166N     P=0.498N     P=0.642      P=0.189N    |P=0.473N     P=0.498N     P=0.759      P=0.511N     | 
|POLY 6             |     P=0.160N     P=0.471N     P=0.627      P=0.177N    |P=0.479N     P=0.493N     P=0.758      P=0.513N     | 
|LOGISTIC REGRESSION|     P=0.162N     P=0.468N     P=0.613      P=0.177N    |P=0.486N     (e)          P=0.747      (e)          | 
|COCH-ARM / FISHERS |     P=0.153N     P=0.500N     P=0.643N     P=0.181N    |P=0.459N     P=0.500N     P=0.753N     P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    3/50 (6%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/41.22      1/41.91      3/40.09      1/40.04     |1/42.15      0/42.89      2/41.48      0/39.32      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         7.5%         2.5%        |2.4%         0.0%         4.8%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    1/29 (3%)    2/25 (8%)    1/28 (4%)   |0/30 (0%)    0/31 (0%)    1/28 (4%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      674          727 (T)     |673          ---          723          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.607N     P=0.738N     P=0.293      P=0.746N    |P=0.479N     P=0.489N     P=0.481      P=0.523N     | 
|POLY 3             |     P=0.633N     P=0.757N     P=0.295      P=0.755     |P=0.478N     P=0.497N     P=0.494      P=0.514N     | 
|POLY 1.5           |     P=0.633N     P=0.760N     P=0.302      P=0.753     |P=0.473N     P=0.498N     P=0.496      P=0.512N     | 
|POLY 6             |     P=0.629N     P=0.752N     P=0.285      P=0.759     |P=0.482N     P=0.495N     P=0.492      P=0.515N     | 
|LOGISTIC REGRESSION|     P=0.625N     P=0.738N     P=0.275      P=0.746N    |P=0.470N     P=0.500N     P=0.495      P=0.505N     | 
|COCH-ARM / FISHERS |     P=0.617N     P=0.753N     P=0.309      P=0.753N    |P=0.450N     P=0.500N     P=0.500      P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    4/50 (8%)    2/50 (4%)   |1/50 (2%)    0/50 (0%)    3/50 (6%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/41.46      3/41.91      4/40.09      2/40.29     |1/42.15      0/42.89      3/41.71      0/39.32      | 
|POLY-3 PERCENT (g) |     7.2%         7.2%         10.0%        5.0%        |2.4%         0.0%         7.2%         0.0%         | 
|TERMINAL (d)       |     2/26 (8%)    3/29 (10%)   3/25 (12%)   1/28 (4%)   |0/30 (0%)    0/31 (0%)    1/28 (4%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     661          727 (T)      674          661         |673          ---          667          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.387N     P=0.616N     P=0.478      P=0.475N    |P=0.475N     P=0.489N     P=0.297      P=0.523N     | 
|POLY 3             |     P=0.418N     P=0.658N     P=0.482      P=0.513N    |P=0.478N     P=0.497N     P=0.301      P=0.514N     | 
|POLY 1.5           |     P=0.420N     P=0.662      P=0.494      P=0.516N    |P=0.472N     P=0.498N     P=0.302      P=0.512N     | 
|POLY 6             |     P=0.410N     P=0.649N     P=0.464      P=0.504N    |P=0.483N     P=0.495N     P=0.300      P=0.515N     | 
|LOGISTIC REGRESSION|     P=0.412N     P=0.641N     P=0.462      P=0.511N    |P=0.462N     P=0.500N     P=0.301      P=0.505N     | 
|COCH-ARM / FISHERS |     P=0.399N     P=0.661N     P=0.500      P=0.500N    |P=0.442N     P=0.500N     P=0.309      P=0.500N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/41.46      2/41.91      1/39.89      1/40.29     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     4.8%         4.8%         2.5%         2.5%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    2/29 (7%)    1/25 (4%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     661          727 (T)      727 (T)      661         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.376N     P=0.659N     P=0.516N     P=0.485N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.393N     P=0.691N     P=0.514N     P=0.510N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.395N     P=0.693      P=0.505N     P=0.513N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.388N     P=0.684N     P=0.526N     P=0.503N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.394N     P=0.683N     P=0.520N     P=0.508N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.383N     P=0.691N     P=0.500N     P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/41.46      2/41.91      1/39.89      1/40.29     |0/41.94      0/42.89      1/41.69      0/39.32      | 
|POLY-3 PERCENT (g) |     4.8%         4.8%         2.5%         2.5%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    2/29 (7%)    1/25 (4%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     661          727 (T)      727 (T)      661         |---          ---          667          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.376N     P=0.659N     P=0.516N     P=0.485N    |P=0.800N     (e)          P=0.505      (e)          | 
|POLY 3             |     P=0.393N     P=0.691N     P=0.514N     P=0.510N    |P=0.796N     (e)          P=0.499      (e)          | 
|POLY 1.5           |     P=0.395N     P=0.693      P=0.505N     P=0.513N    |P=0.794N     (e)          P=0.499      (e)          | 
|POLY 6             |     P=0.388N     P=0.684N     P=0.526N     P=0.503N    |P=0.797N     (e)          P=0.499      (e)          | 
|LOGISTIC REGRESSION|     P=0.394N     P=0.683N     P=0.520N     P=0.508N    |P=0.787N     (e)          P=0.500      (e)          | 
|COCH-ARM / FISHERS |     P=0.383N     P=0.691N     P=0.500N     P=0.500N    |P=0.785N     (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Keratoacanthoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    3/50 (6%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/41.22      3/42.14      3/40.53      1/40.18     |0/41.94      0/42.89      1/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     4.9%         7.1%         7.4%         2.5%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     2/26 (8%)    2/29 (7%)    0/25 (0%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    1/28 (4%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      668          630          691         |---          ---          728 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.309N     P=0.547      P=0.463      P=0.483N    |P=0.802N     (e)          P=0.486      (e)          | 
|POLY 3             |     P=0.319N     P=0.510      P=0.492      P=0.509N    |P=0.796N     (e)          P=0.498      (e)          | 
|POLY 1.5           |     P=0.321N     P=0.502      P=0.498      P=0.512N    |P=0.794N     (e)          P=0.498      (e)          | 
|POLY 6             |     P=0.311N     P=0.524      P=0.485      P=0.500N    |P=0.797N     (e)          P=0.497      (e)          | 
|LOGISTIC REGRESSION|     P=0.317N     P=0.522      P=0.486      P=0.502N    |(e)          (e)          P=0.486      (e)          | 
|COCH-ARM / FISHERS |     P=0.304N     P=0.500      P=0.500      P=0.500N    |P=0.785N     (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    4/50 (8%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/41.22      3/42.14      4/40.53      1/40.18     |0/41.94      0/42.89      1/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     7.3%         7.1%         9.9%         2.5%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     3/26 (12%)   2/29 (7%)    1/25 (4%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    1/28 (4%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      668          630          691         |---          ---          728 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.222N     P=0.614N     P=0.462      P=0.286N    |P=0.802N     (e)          P=0.486      (e)          | 
|POLY 3             |     P=0.233N     P=0.653N     P=0.491      P=0.314N    |P=0.796N     (e)          P=0.498      (e)          | 
|POLY 1.5           |     P=0.235N     P=0.661N     P=0.498      P=0.317N    |P=0.794N     (e)          P=0.498      (e)          | 
|POLY 6             |     P=0.227N     P=0.639N     P=0.482      P=0.305N    |P=0.797N     (e)          P=0.497      (e)          | 
|LOGISTIC REGRESSION|     P=0.229N     P=0.639N     P=0.473      P=0.304N    |(e)          (e)          P=0.486      (e)          | 
|COCH-ARM / FISHERS |     P=0.218N     P=0.661N     P=0.500      P=0.309N    |P=0.785N     (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    3/50 (6%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     3/41.22      3/42.14      3/40.53      1/40.18     |0/41.94      0/42.89      1/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     7.3%         7.1%         7.4%         2.5%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     3/26 (12%)   2/29 (7%)    0/25 (0%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    1/28 (4%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      668          630          691         |---          ---          728 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.220N     P=0.614N     P=0.625      P=0.286N    |P=0.802N     (e)          P=0.486      (e)          | 
|POLY 3             |     P=0.228N     P=0.653N     P=0.655      P=0.314N    |P=0.796N     (e)          P=0.498      (e)          | 
|POLY 1.5           |     P=0.229N     P=0.661N     P=0.661      P=0.317N    |P=0.794N     (e)          P=0.498      (e)          | 
|POLY 6             |     P=0.222N     P=0.639N     P=0.649      P=0.305N    |P=0.797N     (e)          P=0.497      (e)          | 
|LOGISTIC REGRESSION|     P=0.225N     P=0.639N     P=0.645      P=0.304N    |(e)          (e)          P=0.486      (e)          | 
|COCH-ARM / FISHERS |     P=0.215N     P=0.661N     P=0.661N     P=0.309N    |P=0.785N     (e)          P=0.500      (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 14      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Sebaceous Gland                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/41.22      1/41.91      1/39.89      2/40.30     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         2.5%         5.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    1/29 (3%)    1/25 (4%)    0/28 (0%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      679         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.367      P=0.738N     P=0.754      P=0.509     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.351      P=0.757N     P=0.754      P=0.492     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.349      P=0.760N     P=0.758      P=0.488     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.357      P=0.752N     P=0.747      P=0.502     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.353      P=0.738N     P=0.754      P=0.493     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.361      P=0.753N     P=0.753N     P=0.500     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Sebaceous Gland                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/50 (4%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/41.22      1/41.91      2/40.24      3/40.30     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         5.0%         7.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/26 (4%)    1/29 (3%)    1/25 (4%)    1/28 (4%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     727 (T)      727 (T)      630          679         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.189      P=0.738N     P=0.485      P=0.321     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.172      P=0.757N     P=0.492      P=0.297     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.171      P=0.760N     P=0.498      P=0.293     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.177      P=0.752N     P=0.483      P=0.306     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.172      P=0.738N     P=0.488      P=0.299     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.182      P=0.753N     P=0.500      P=0.309     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 15      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     44/50 (88%)  43/50 (86%)  43/50 (86%)  40/50 (80%) |                                                    | 
|POLY-3 RATE (b)    |     44/47.31     43/46.30     43/47.00     40/44.46    |                                                    | 
|POLY-3 PERCENT (g) |     93.0%        92.9%        91.5%        90.0%       |                                                    | 
|TERMINAL (d)       |     26/26 (100%) 28/29 (97%)  24/25 (96%)  26/28 (93%) |                                                    | 
|FIRST INCIDENCE    |     475          503          484          433         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.250N     P=0.262N     P=0.491      P=0.211N    |                                                    | 
|POLY 3             |     P=0.346N     P=0.658N     P=0.550N     P=0.435N    |                                                    | 
|POLY 1.5           |     P=0.310N     P=0.644N     P=0.493N     P=0.393N    |                                                    | 
|POLY 6             |     P=0.353N     P=0.615N     P=0.613N     P=0.427N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.342N     P=0.581N     P=0.508N     P=0.388N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.160N     P=0.500N     P=0.500N     P=0.207N    |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   8/50 (16%)   8/50 (16%)   7/50 (14%)  |11/50 (22%)  8/50 (16%)   10/50 (20%)  9/50 (18%)   | 
|POLY-3 RATE (b)    |     8/42.32      8/42.22      8/40.54      7/40.22     |11/42.19     8/42.98      10/41.91     9/40.05      | 
|POLY-3 PERCENT (g) |     18.9%        19.0%        19.7%        17.4%       |26.1%        18.6%        23.9%        22.5%        | 
|TERMINAL (d)       |     6/26 (23%)   7/29 (24%)   6/25 (24%)   5/28 (18%)  |9/30 (30%)   6/31 (19%)   6/28 (21%)   5/27 (19%)   | 
|FIRST INCIDENCE    |     519          645          582          689         |673          715          673          651          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.417N     P=0.526N     P=0.571      P=0.459N    |P=0.534      P=0.282N     P=0.567N     P=0.494N     | 
|POLY 3             |     P=0.486N     P=0.607      P=0.573      P=0.543N    |P=0.536N     P=0.285N     P=0.507N     P=0.451N     | 
|POLY 1.5           |     P=0.482N     P=0.600      P=0.593      P=0.541N    |P=0.530N     P=0.294N     P=0.507N     P=0.450N     | 
|POLY 6             |     P=0.482N     P=0.598N     P=0.544      P=0.535N    |P=0.531N     P=0.275N     P=0.506N     P=0.441N     | 
|LOGISTIC REGRESSION|     P=0.465N     P=0.595N     P=0.583      P=0.521N    |P=0.562N     P=0.260N     P=0.522N     P=0.464N     | 
|COCH-ARM / FISHERS |     P=0.439N     P=0.607N     P=0.607N     P=0.500N    |P=0.469N     P=0.306N     P=0.500N     P=0.402N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 16      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/42.07      1/42.19      0/39.89      1/40.04     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     4.8%         2.4%         0.0%         2.5%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/26 (0%)    0/29 (0%)    0/25 (0%)    1/28 (4%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     573          654          ---          727 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.498N     P=0.482N     P=0.246N     P=0.491N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.507N     P=0.499N     P=0.249N     P=0.517N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.506N     P=0.502N     P=0.242N     P=0.516N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.508N     P=0.493N     P=0.259N     P=0.515N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.493N     P=0.494N     P=0.248N     P=0.495N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.500N     P=0.247N     P=0.500N    |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/50 (20%)  9/50 (18%)   8/50 (16%)   8/50 (16%)  |11/50 (22%)  8/50 (16%)   10/50 (20%)  9/50 (18%)   | 
|POLY-3 RATE (b)    |     10/43.18     9/42.49      8/40.54      8/40.22     |11/42.19     8/42.98      10/41.91     9/40.05      | 
|POLY-3 PERCENT (g) |     23.2%        21.2%        19.7%        19.9%       |26.1%        18.6%        23.9%        22.5%        | 
|TERMINAL (d)       |     6/26 (23%)   7/29 (24%)   6/25 (24%)   6/28 (21%)  |9/30 (30%)   6/31 (19%)   6/28 (21%)   5/27 (19%)   | 
|FIRST INCIDENCE    |     519          645          582          689         |673          715          673          651          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.361N     P=0.417N     P=0.436N     P=0.360N    |P=0.534      P=0.282N     P=0.567N     P=0.494N     | 
|POLY 3             |     P=0.440N     P=0.516N     P=0.454N     P=0.462N    |P=0.536N     P=0.285N     P=0.507N     P=0.451N     | 
|POLY 1.5           |     P=0.429N     P=0.517N     P=0.423N     P=0.452N    |P=0.530N     P=0.294N     P=0.507N     P=0.450N     | 
|POLY 6             |     P=0.446N     P=0.507N     P=0.499N     P=0.465N    |P=0.531N     P=0.275N     P=0.506N     P=0.441N     | 
|LOGISTIC REGRESSION|     P=0.410N     P=0.497N     P=0.410N     P=0.422N    |P=0.562N     P=0.260N     P=0.522N     P=0.464N     | 
|COCH-ARM / FISHERS |     P=0.380N     P=0.500N     P=0.398N     P=0.398N    |P=0.469N     P=0.306N     P=0.500N     P=0.402N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 17      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/41.22      1/41.91      1/39.89      3/40.12     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         2.5%         7.5%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/26 (0%)    1/29 (3%)    1/25 (4%)    2/28 (7%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     ---          727 (T)      727 (T)      707         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.069      P=0.522      P=0.492      P=0.131     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.059      P=0.503      P=0.493      P=0.113     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.059      P=0.500      P=0.498      P=0.112     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.061      P=0.509      P=0.487      P=0.117     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.061      P=0.522      P=0.492      P=0.119     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.064      P=0.500      P=0.500      P=0.121     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/41.22      1/42.48      0/39.89      1/40.04     |1/41.94      0/42.89      0/41.46      1/39.32      | 
|POLY-3 PERCENT (g) |     4.9%         2.4%         0.0%         2.5%        |2.4%         0.0%         0.0%         2.5%         | 
|TERMINAL (d)       |     2/26 (8%)    0/29 (0%)    0/25 (0%)    1/28 (4%)   |1/30 (3%)    0/31 (0%)    0/28 (0%)    1/27 (4%)    | 
|FIRST INCIDENCE    |     727 (T)      551          ---          727 (T)     |728 (T)      ---          ---          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.494N     P=0.469N     P=0.246N     P=0.474N    |P=0.514      P=0.493N     P=0.514N     P=0.739      | 
|POLY 3             |     P=0.508N     P=0.489N     P=0.244N     P=0.510N    |P=0.524      P=0.496N     P=0.502N     P=0.746      | 
|POLY 1.5           |     P=0.507N     P=0.497N     P=0.240N     P=0.513N    |P=0.527      P=0.498N     P=0.502N     P=0.748      | 
|POLY 6             |     P=0.509N     P=0.478N     P=0.251N     P=0.503N    |P=0.521      P=0.493N     P=0.503N     P=0.746      | 
|LOGISTIC REGRESSION|     P=0.508N     P=0.500N     (e)          P=0.474N    |P=0.514      (e)          (e)          P=0.739      | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.500N     P=0.247N     P=0.500N    |P=0.541      P=0.500N     P=0.500N     P=0.753N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 18      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    1/50 (2%)    4/50 (8%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     2/41.22      2/42.48      1/39.89      4/40.12     |1/41.94      0/42.89      0/41.46      1/39.32      | 
|POLY-3 PERCENT (g) |     4.9%         4.7%         2.5%         10.0%       |2.4%         0.0%         0.0%         2.5%         | 
|TERMINAL (d)       |     2/26 (8%)    1/29 (3%)    1/25 (4%)    3/28 (11%)  |1/30 (3%)    0/31 (0%)    0/28 (0%)    1/27 (4%)    | 
|FIRST INCIDENCE    |     727 (T)      551          727 (T)      707         |728 (T)      ---          ---          728 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.206      P=0.660N     P=0.514N     P=0.365     |P=0.514      P=0.493N     P=0.514N     P=0.739      | 
|POLY 3             |     P=0.184      P=0.683N     P=0.511N     P=0.324     |P=0.524      P=0.496N     P=0.502N     P=0.746      | 
|POLY 1.5           |     P=0.184      P=0.691N     P=0.504N     P=0.321     |P=0.527      P=0.498N     P=0.502N     P=0.748      | 
|POLY 6             |     P=0.186      P=0.672N     P=0.522N     P=0.334     |P=0.521      P=0.493N     P=0.503N     P=0.746      | 
|LOGISTIC REGRESSION|     P=0.186      P=0.694N     P=0.514N     P=0.331     |P=0.514      (e)          (e)          P=0.739      | 
|COCH-ARM / FISHERS |     P=0.196      P=0.691N     P=0.500N     P=0.339     |P=0.541      P=0.500N     P=0.500N     P=0.753N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |7/50 (14%)   8/50 (16%)   7/50 (14%)   6/50 (12%)   | 
|POLY-3 RATE (b)    |                                                        |7/42.67      8/42.99      7/42.31      6/39.59      | 
|POLY-3 PERCENT (g) |                                                        |16.4%        18.6%        16.6%        15.2%        | 
|TERMINAL (d)       |                                                        |5/30 (17%)   6/31 (19%)   4/28 (14%)   5/27 (19%)   | 
|FIRST INCIDENCE    |                                                        |621          716          559          656          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.481N     P=0.529      P=0.578      P=0.565N     | 
|POLY 3             |                                                        |P=0.453N     P=0.506      P=0.608      P=0.558N     | 
|POLY 1.5           |                                                        |P=0.442N     P=0.504      P=0.608      P=0.549N     | 
|POLY 6             |                                                        |P=0.461N     P=0.508      P=0.607      P=0.565N     | 
|LOGISTIC REGRESSION|                                                        |P=0.450N     P=0.526      P=0.607      P=0.549N     | 
|COCH-ARM / FISHERS |                                                        |P=0.385N     P=0.500      P=0.613N     P=0.500N     | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 19      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal or Polyp Stromal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |7/50 (14%)   8/50 (16%)   7/50 (14%)   7/50 (14%)   | 
|POLY-3 RATE (b)    |                                                        |7/42.67      8/42.99      7/42.31      7/39.88      | 
|POLY-3 PERCENT (g) |                                                        |16.4%        18.6%        16.6%        17.6%        | 
|TERMINAL (d)       |                                                        |5/30 (17%)   6/31 (19%)   4/28 (14%)   5/27 (19%)   | 
|FIRST INCIDENCE    |                                                        |621          716          559          651          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.524      P=0.529      P=0.578      P=0.551      | 
|POLY 3             |                                                        |P=0.554      P=0.506      P=0.608      P=0.561      | 
|POLY 1.5           |                                                        |P=0.562      P=0.504      P=0.608      P=0.567      | 
|POLY 6             |                                                        |P=0.551      P=0.508      P=0.607      P=0.560      | 
|LOGISTIC REGRESSION|                                                        |P=0.554      P=0.526      P=0.607      P=0.567      | 
|COCH-ARM / FISHERS |                                                        |P=0.517N     P=0.500      P=0.613N     P=0.613N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     15/50 (30%)  16/50 (32%)  12/50 (24%)  16/50 (32%) |7/50 (14%)   14/50 (28%)  8/50 (16%)   10/50 (20%)  | 
|POLY-3 RATE (b)    |     15/44.05     16/45.08     12/42.28     16/42.12    |7/43.03      14/45.28     8/43.35      10/41.99     | 
|POLY-3 PERCENT (g) |     34.1%        35.5%        28.4%        38.0%       |16.3%        30.9%        18.5%        23.8%        | 
|TERMINAL (d)       |     5/26 (19%)   4/29 (14%)   4/25 (16%)   8/28 (29%)  |4/30 (13%)   6/31 (19%)   2/28 (7%)    2/27 (7%)    | 
|FIRST INCIDENCE    |     519          313          526          484         |596          510          491          495          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.470      P=0.567N     P=0.411N     P=0.529     |P=0.444      P=0.101      P=0.491      P=0.264      | 
|POLY 3             |     P=0.401      P=0.532      P=0.368N     P=0.438     |P=0.493      P=0.084      P=0.506      P=0.275      | 
|POLY 1.5           |     P=0.408      P=0.511      P=0.342N     P=0.438     |P=0.489      P=0.076      P=0.501      P=0.269      | 
|POLY 6             |     P=0.408      P=0.563      P=0.403N     P=0.457     |P=0.507      P=0.094      P=0.513      P=0.288      | 
|LOGISTIC REGRESSION|     P=0.454      P=0.500      P=0.328N     P=0.468     |P=0.529      P=0.071      P=0.500      P=0.288      | 
|COCH-ARM / FISHERS |     P=0.478      P=0.500      P=0.326N     P=0.500     |P=0.536      P=0.070      P=0.500      P=0.298      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 20      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Benign, Malignant, NOS                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    4/50 (8%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/41.35      0/41.91      2/39.89      4/40.84     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         5.0%         9.8%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/26 (0%)    0/29 (0%)    2/25 (8%)    2/28 (7%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     699          ---          727 (T)      604         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.097      P=0.230N     P=0.651      P=0.354     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.084      P=0.234N     P=0.682      P=0.331     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.083      P=0.237N     P=0.690      P=0.324     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.087      P=0.229N     P=0.669      P=0.345     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.083      P=0.229N     P=0.661      P=0.325     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.090      P=0.247N     P=0.691N     P=0.339     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Malignant                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    4/50 (8%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     2/41.35      0/41.91      2/39.89      4/40.84     |0/41.94      0/42.89      0/41.46      0/39.32      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         5.0%         9.8%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/26 (0%)    0/29 (0%)    2/25 (8%)    2/28 (7%)   |0/30 (0%)    0/31 (0%)    0/28 (0%)    0/27 (0%)    | 
|FIRST INCIDENCE    |     699          ---          727 (T)      604         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.097      P=0.230N     P=0.651      P=0.354     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.084      P=0.234N     P=0.682      P=0.331     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.083      P=0.237N     P=0.690      P=0.324     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.087      P=0.229N     P=0.669      P=0.345     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.083      P=0.229N     P=0.661      P=0.325     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.090      P=0.247N     P=0.691N     P=0.339     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 21      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     49/50 (98%)  47/50 (94%)  49/50 (98%)  45/50 (90%) |37/50 (74%)  41/50 (82%)  41/50 (82%)  35/50 (70%)  | 
|POLY-3 RATE (b)    |     49/49.00     47/47.99     49/49.19     45/45.21    |37/46.19     41/46.12     41/45.50     35/42.20     | 
|POLY-3 PERCENT (g) |     100.0%       97.9%        99.6%        99.5%       |80.1%        88.9%        90.1%        83.0%        | 
|TERMINAL (d)       |     26/26 (100%) 29/29 (100%) 25/25 (100%) 28/28 (100%)|22/30 (73%)  28/31 (90%)  26/28 (93%)  22/27 (82%)  | 
|FIRST INCIDENCE    |     475          313          462          433         |462          474          474          525          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.300N     P=0.225N     P=0.408      P=0.233N    |P=0.522      P=0.385      P=0.211      P=0.483      | 
|POLY 3             |     P=0.721      P=0.500N     P=1.000N     P=1.000N    |P=0.532N     P=0.176      P=0.132      P=0.471      | 
|POLY 1.5           |     P=0.551N     P=0.429N     P=0.920N     P=0.600N    |P=0.444N     P=0.195      P=0.159      P=0.539      | 
|POLY 6             |     P=0.630      P=0.530N     P=1.000N     P=1.000N    |P=0.566      P=0.152      P=0.103      P=0.421      | 
|LOGISTIC REGRESSION|     P=0.476N     P=0.454N     (e)          (e)         |P=0.424N     P=0.251      P=0.179      P=0.574      | 
|COCH-ARM / FISHERS |     P=0.075N     P=0.309N     P=0.753N     P=0.102N    |P=0.187N     P=0.235      P=0.235      P=0.412N     | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     29/50 (58%)  25/50 (50%)  22/50 (44%)  25/50 (50%) |12/50 (24%)  17/50 (34%)  14/50 (28%)  15/50 (30%)  | 
|POLY-3 RATE (b)    |     29/45.98     25/46.62     22/44.55     25/43.17    |12/44.49     17/45.47     14/45.00     15/43.17     | 
|POLY-3 PERCENT (g) |     63.1%        53.6%        49.4%        57.9%       |27.0%        37.4%        31.1%        34.8%        | 
|TERMINAL (d)       |     11/26 (42%)  9/29 (31%)   9/25 (36%)   14/28 (50%) |6/30 (20%)   8/31 (26%)   4/28 (14%)   4/27 (15%)   | 
|FIRST INCIDENCE    |     475          313          419          484         |406          510          483          379          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.390N     P=0.234N     P=0.254N     P=0.280N    |P=0.348      P=0.244      P=0.394      P=0.275      | 
|POLY 3             |     P=0.499N     P=0.237N     P=0.129N     P=0.388N    |P=0.398      P=0.202      P=0.422      P=0.288      | 
|POLY 1.5           |     P=0.474N     P=0.259N     P=0.112N     P=0.375N    |P=0.394      P=0.194      P=0.411      P=0.283      | 
|POLY 6             |     P=0.505N     P=0.209N     P=0.162N     P=0.378N    |P=0.411      P=0.217      P=0.439      P=0.304      | 
|LOGISTIC REGRESSION|     P=0.396N     P=0.274N     P=0.116N     P=0.326N    |P=0.466      P=0.188      P=0.417      P=0.334      | 
|COCH-ARM / FISHERS |     P=0.354N     P=0.274N     P=0.115N     P=0.274N    |P=0.456      P=0.189      P=0.410      P=0.326      | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/12/01                           EXPERIMENT: 88122 TEST: 06                                            Page 22      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      ELMIRON               
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      14 MG/KG     42 MG/KG     126         |0 MG/KG      28 MG/KG     84 MG/KG     252          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     49/50 (98%)  48/50 (96%)  50/50 (100%) 45/50 (90%) |42/50 (84%)  45/50 (90%)  44/50 (88%)  40/50 (80%)  | 
|POLY-3 RATE (b)    |     49/49.00     48/48.04     50/50.00     45/45.21    |42/47.56     45/47.52     44/46.73     40/45.18     | 
|POLY-3 PERCENT (g) |     100.0%       99.9%        100.0%       99.5%       |88.3%        94.7%        94.2%        88.5%        | 
|TERMINAL (d)       |     26/26 (100%) 29/29 (100%) 25/25 (100%) 28/28 (100%)|25/30 (83%)  29/31 (94%)  26/28 (93%)  22/27 (82%)  | 
|FIRST INCIDENCE    |     475          313          419          433         |406          474          474          379          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.277N     P=0.277N     P=0.354      P=0.233N    |P=0.463      P=0.458      P=0.316      P=0.463      | 
|POLY 3             |     P=1.000N     P=1.000N     P=1.000      P=1.000N    |P=0.396N     P=0.218      P=0.251      P=0.616      | 
|POLY 1.5           |     P=0.176N     P=1.000N     P=1.000      P=0.600N    |P=0.387N     P=0.224      P=0.281      P=0.622      | 
|POLY 6             |     P=1.000N     P=1.000N     P=1.000      P=1.000N    |P=0.363N     P=0.219      P=0.234      P=0.618N     | 
|LOGISTIC REGRESSION|     P=0.195N     (e)          (e)          (e)         |P=0.465N     P=0.284      P=0.331      P=0.602      | 
|COCH-ARM / FISHERS |     P=0.031N*    P=0.500N     P=0.500      P=0.102N    |P=0.182N     P=0.277      P=0.387      P=0.398N     | 
|=================================================================================================================================| 
(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).