NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                          PULEGONE                                       DATE: 03/31/04       
EXPERIMENT: 99020 TEST: 03                                                                                     TIME: 14:51:53       
TEST TYPE:  SUBCHRON 90-DAY                     CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-15460                              ROUTE: GAVAGE                                                  NTP C#: C99020       
PATHOLOGIST: MISSING                                                                                           CAS: 89-82-7         
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                                                           FINAL #1 RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                          PULEGONE                                       DATE: 03/31/04       
EXPERIMENT: 99020 TEST: 03                                                                                     TIME: 14:51:53       
TEST TYPE:  SUBCHRON 90-DAY                     CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-15460                              ROUTE: GAVAGE                                                  NTP C#: C99020       
PATHOLOGIST: MISSING                                                                                           CAS: 89-82-7         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                        PULEGONE                                                                                  
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Bone Marrow                            Hyperplasia                                                                                  
Heart                                  Mineralization                                                                               
Kidney                                 Accumulation, Hyaline Droplet                                                                
Kidney: Renal Tubule                   Casts Protein                                                                                
                                       Regeneration                                                                                 
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Hypertrophy                                                                                  
                                       Necrosis Focal                                                                               
Liver: Oval Cell                       Hyperplasia                                                                                  
Liver: Periportal                      Fibrosis                                                                                     
Lung                                   Infiltration Cellular Histiocyte                                                             
Lung: Interstitium                     Infiltration Cellular Lymphocyte                                                             
Stomach, Glandular                     Mineralization                                                                               
Testes: Germinal Epithelium            Degeneration                                                                                 
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Bone Marrow                            Hyperplasia                                                                                  
Heart                                  Cardiomyopathy                                                                               
Kidney                                 Mineralization                                                                               
Kidney: Renal Tubule                   Casts Protein                                                                                
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Hypertrophy                                                                                  
Liver: Oval Cell                       Hyperplasia                                                                                  
Liver: Periportal                      Fibrosis                                                                                     
Lung                                   Infiltration Cellular Histiocyte                                                             
Lung: Interstitium                     Infiltration Cellular Lymphocyte                                                             
Ovary                                  Cyst                                                                                         
Stomach, Glandular                     Mineralization                                                                               
Uterus                                 Dilatation                                                                                   
===============================================================                                                                     
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                         PULEGONE 
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       1/10 (10%)       5/10 (50%)       9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        3/10.00          1/10.00          5/10.00          9/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        30.0%            10.0%            50.0%            90.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        3/10 (30%)       1/10 (10%)       5/10 (50%)       9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.293N         P=0.328          P=0.013 *        P=0.003 **       P=0.003 **      | 
|POLY 3             |        P<0.001 **       P=0.292N         P=0.329          P=0.003 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.292N         P=0.329          P=0.003 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.292N         P=0.329          P=0.003 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.293N         P=0.328          P=0.013 *        P=0.003 **       P=0.003 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.291N         P=0.325          P=0.010 *        P=0.002 **       P=0.002 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       1/10 (10%)       1/10 (10%)       1/10 (10%)       10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        1/10.00          1/10.00          1/10.00          1/10.00          10/10.00         9/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            10.0%            10.0%            10.0%            100.0%           90.0%           | 
|TERMINAL (d)       |        1/10 (10%)       1/10 (10%)       1/10 (10%)       1/10 (10%)       10/10 (100%)     8/9 (89%)       | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           9               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.766          P=0.766          P=0.766          P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.760          P=0.760          P=0.760          P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.760          P=0.760          P=0.760          P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.760          P=0.760          P=0.760          P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.766          P=0.766          P=0.766          P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.763N         P=0.763N         P=0.763N         P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       8/10 (80%)       8/10 (80%)       9/10 (90%)       7/10 (70%)       7/10 (70%)      | 
|POLY-3 RATE (b)    |        9/10.00          8/10.00          8/10.00          9/10.00          7/10.00          7/10.00         | 
|POLY-3 PERCENT (g) |        90.0%            80.0%            80.0%            90.0%            70.0%            70.0%           | 
|TERMINAL (d)       |        9/10 (90%)       8/10 (80%)       8/10 (80%)       9/10 (90%)       7/10 (70%)       7/10 (70%)      | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.175N         P=0.500N         P=0.500N         P=0.766          P=0.293N         P=0.293N        | 
|POLY 3             |        P=0.181N         P=0.500N         P=0.500N         P=0.760          P=0.292N         P=0.292N        | 
|POLY 1.5           |        P=0.181N         P=0.500N         P=0.500N         P=0.760          P=0.292N         P=0.292N        | 
|POLY 6             |        P=0.181N         P=0.500N         P=0.500N         P=0.760          P=0.292N         P=0.292N        | 
|LOGISTIC REGRESSION|        P=0.175N         P=0.500N         P=0.500N         P=0.766          P=0.293N         P=0.293N        | 
|COCH-ARM / FISHERS |        P=0.173N         P=0.500N         P=0.500N         P=0.763N         P=0.291N         P=0.291N        | 
|ORDER RESTRICTED   |        P=0.245N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/10 (60%)       3/10 (30%)       0/10 (0%)        4/10 (40%)       5/10 (50%)       2/10 (20%)      | 
|POLY-3 RATE (b)    |        6/10.00          3/10.00          0/10.00          4/10.00          5/10.00          2/9.00          | 
|POLY-3 PERCENT (g) |        60.0%            30.0%            0.0%             40.0%            50.0%            22.2%           | 
|TERMINAL (d)       |        6/10 (60%)       3/10 (30%)       0/10 (0%)        4/10 (40%)       5/10 (50%)       2/9 (22%)       | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           ---              94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.406N         P=0.190N         P=0.009N**       P=0.331N         P=0.500N         P=0.121N        | 
|POLY 3             |        P=0.411N         P=0.186N         P<0.001N**       P=0.333N         P=0.500N         P=0.111N        | 
|POLY 1.5           |        P=0.408N         P=0.186N         P<0.001N**       P=0.333N         P=0.500N         P=0.109N        | 
|POLY 6             |        P=0.411N         P=0.186N         P<0.001N**       P=0.333N         P=0.500N         P=0.111N        | 
|LOGISTIC REGRESSION|        P=0.406N         P=0.190N         (e)              P=0.331N         P=0.500N         P=0.121N        | 
|COCH-ARM / FISHERS |        P=0.339N         P=0.185N         P=0.005N**       P=0.328N         P=0.500N         P=0.085N        | 
|ORDER RESTRICTED   |        P=0.057N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/10 (0%)        0/10 (0%)        1/10 (10%)       0/10 (0%)        6/10 (60%)      | 
|POLY-3 RATE (b)    |        1/10.00          0/10.00          0/10.00          1/10.00          0/10.00          6/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             10.0%            0.0%             60.0%           | 
|TERMINAL (d)       |        1/10 (10%)       0/10 (0%)        0/10 (0%)        1/10 (10%)       0/10 (0%)        6/10 (60%)      | 
|FIRST INCIDENCE    |        94 (T)           ---              ---              94 (T)           ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500N         P=0.500N         P=0.766          P=0.500N         P=0.034 *       | 
|POLY 3             |        P<0.001 **       P=0.500N         P=0.500N         P=0.760          P=0.500N         P=0.018 *       | 
|POLY 1.5           |        P<0.001 **       P=0.500N         P=0.500N         P=0.760          P=0.500N         P=0.018 *       | 
|POLY 6             |        P<0.001 **       P=0.500N         P=0.500N         P=0.760          P=0.500N         P=0.018 *       | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P=0.766          (e)              P=0.034 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500N         P=0.763N         P=0.500N         P=0.029 *       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          1/9.00          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             11.1%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/9 (11%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.095          (e)              (e)              (e)              (e)              P=0.479         | 
|POLY 3             |        P=0.098          (e)              (e)              (e)              (e)              P=0.479         | 
|POLY 1.5           |        P=0.098          (e)              (e)              (e)              (e)              P=0.480         | 
|POLY 6             |        P=0.098          (e)              (e)              (e)              (e)              P=0.479         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.479         | 
|COCH-ARM / FISHERS |        P=0.105          (e)              (e)              (e)              (e)              P=0.500         | 
|ORDER RESTRICTED   |        P=0.050          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/10 (0%)        1/10 (10%)       1/10 (10%)       0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        3/10.00          0/10.00          1/10.00          1/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        30.0%            0.0%             10.0%            10.0%            0.0%             0.0%            | 
|TERMINAL (d)       |        3/10 (30%)       0/10 (0%)        1/10 (10%)       1/10 (10%)       0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        94 (T)           ---              94 (T)           94 (T)           ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.091N         P=0.111N         P=0.293N         P=0.293N         P=0.111N         P=0.111N        | 
|POLY 3             |        P=0.083N         P=0.095N         P=0.292N         P=0.292N         P=0.095N         P=0.095N        | 
|POLY 1.5           |        P=0.083N         P=0.095N         P=0.292N         P=0.292N         P=0.095N         P=0.095N        | 
|POLY 6             |        P=0.083N         P=0.095N         P=0.292N         P=0.292N         P=0.095N         P=0.095N        | 
|LOGISTIC REGRESSION|        P=0.091N         (e)              P=0.293N         P=0.293N         (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.089N         P=0.105N         P=0.291N         P=0.291N         P=0.105N         P=0.105N        | 
|ORDER RESTRICTED   |        P=0.009N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.00          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/10 (60%)       8/10 (80%)       8/10 (80%)       7/10 (70%)       9/10 (90%)       7/10 (70%)      | 
|POLY-3 RATE (b)    |        6/10.00          8/10.00          8/10.00          7/10.00          9/10.00          7/10.00         | 
|POLY-3 PERCENT (g) |        60.0%            80.0%            80.0%            70.0%            90.0%            70.0%           | 
|TERMINAL (d)       |        6/10 (60%)       8/10 (80%)       8/10 (80%)       7/10 (70%)       9/10 (90%)       7/10 (70%)      | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.511          P=0.317          P=0.317          P=0.500          P=0.157          P=0.500         | 
|POLY 3             |        P=0.511          P=0.318          P=0.318          P=0.500          P=0.148          P=0.500         | 
|POLY 1.5           |        P=0.511          P=0.318          P=0.318          P=0.500          P=0.148          P=0.500         | 
|POLY 6             |        P=0.511          P=0.318          P=0.318          P=0.500          P=0.148          P=0.500         | 
|LOGISTIC REGRESSION|        P=0.511          P=0.317          P=0.317          P=0.500          P=0.157          P=0.500         | 
|COCH-ARM / FISHERS |        P=0.511          P=0.314          P=0.314          P=0.500          P=0.152          P=0.500         | 
|ORDER RESTRICTED   |        P=0.281          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/10 (60%)       10/10 (100%)     9/10 (90%)       9/10 (90%)       10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        6/10.00          10/10.00         9/10.00          9/10.00          10/10.00         9/10.00         | 
|POLY-3 PERCENT (g) |        60.0%            100.0%           90.0%            90.0%            100.0%           90.0%           | 
|TERMINAL (d)       |        6/10 (60%)       10/10 (100%)     9/10 (90%)       9/10 (90%)       10/10 (100%)     8/9 (89%)       | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           9               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.087          P=0.051          P=0.157          P=0.157          P=0.051          P=0.108         | 
|POLY 3             |        P=0.218          P=0.033 *        P=0.148          P=0.148          P=0.033 *        P=0.148         | 
|POLY 1.5           |        P=0.218          P=0.033 *        P=0.148          P=0.148          P=0.033 *        P=0.148         | 
|POLY 6             |        P=0.218          P=0.033 *        P=0.148          P=0.148          P=0.033 *        P=0.148         | 
|LOGISTIC REGRESSION|        P=0.087          P=0.051          P=0.157          P=0.157          P=0.051          (e)             | 
|COCH-ARM / FISHERS |        P=0.228          P=0.043 *        P=0.152          P=0.152          P=0.043 *        P=0.152         | 
|ORDER RESTRICTED   |        P=0.008 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/10 (70%)       4/10 (40%)       6/10 (60%)       6/10 (60%)       4/10 (40%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        7/10.00          4/10.00          6/10.00          6/10.00          4/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        70.0%            40.0%            60.0%            60.0%            40.0%            100.0%          | 
|TERMINAL (d)       |        7/10 (70%)       4/10 (40%)       6/10 (60%)       6/10 (60%)       4/10 (40%)       10/10 (100%)    | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.039 *        P=0.190N         P=0.500N         P=0.500N         P=0.190N         P=0.111         | 
|POLY 3             |        P=0.031 *        P=0.186N         P=0.500N         P=0.500N         P=0.186N         P=0.095         | 
|POLY 1.5           |        P=0.031 *        P=0.186N         P=0.500N         P=0.500N         P=0.186N         P=0.095         | 
|POLY 6             |        P=0.031 *        P=0.186N         P=0.500N         P=0.500N         P=0.186N         P=0.095         | 
|LOGISTIC REGRESSION|        P=0.039 *        P=0.190N         P=0.500N         P=0.500N         P=0.190N         P=0.111         | 
|COCH-ARM / FISHERS |        P=0.037 *        P=0.185N         P=0.500N         P=0.500N         P=0.185N         P=0.105         | 
|ORDER RESTRICTED   |        P=0.018 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Casts Protein                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       6/10 (60%)      | 
|POLY-3 RATE (b)    |        1/10.00          0/10.00          0/10.00          0/10.00          2/10.00          6/9.00          | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             20.0%            66.7%           | 
|TERMINAL (d)       |        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       6/9 (67%)       | 
|FIRST INCIDENCE    |        94 (T)           ---              ---              ---              94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.021 *       | 
|POLY 3             |        P<0.001 **       P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.008 **      | 
|POLY 1.5           |        P<0.001 **       P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.008 **      | 
|POLY 6             |        P<0.001 **       P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.008 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              (e)              P=0.500          P=0.021 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.029 *       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Regeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       9/10 (90%)       10/10 (100%)     10/10 (100%)     3/10 (30%)       9/10 (90%)      | 
|POLY-3 RATE (b)    |        9/10.00          9/10.00          10/10.00         10/10.00         3/10.00          9/10.00         | 
|POLY-3 PERCENT (g) |        90.0%            90.0%            100.0%           100.0%           30.0%            90.0%           | 
|TERMINAL (d)       |        9/10 (90%)       9/10 (90%)       10/10 (100%)     10/10 (100%)     3/10 (30%)       9/10 (90%)      | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.139N         P=0.766          P=0.500          P=0.500          P=0.013N*        P=0.766         | 
|POLY 3             |        P=0.086N         P=0.760          P=0.500          P=0.500          P=0.003N**       P=0.760         | 
|POLY 1.5           |        P=0.086N         P=0.760          P=0.500          P=0.500          P=0.003N**       P=0.760         | 
|POLY 6             |        P=0.086N         P=0.760          P=0.500          P=0.500          P=0.003N**       P=0.760         | 
|LOGISTIC REGRESSION|        P=0.139N         P=0.766          P=0.500          P=0.500          P=0.013N*        P=0.766         | 
|COCH-ARM / FISHERS |        P=0.137N         P=0.763N         P=0.500          P=0.500          P=0.010N*        P=0.763N        | 
|ORDER RESTRICTED   |        P=0.006N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Regeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          1/10.00          0/10.00          0/10.00          0/10.00          0/9.00          | 
|POLY-3 PERCENT (g) |        0.0%             10.0%            0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        ---              94 (T)           ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.501N         P=0.500          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.471N         P=0.500          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.472N         P=0.500          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.471N         P=0.500          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              P=0.500          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.488N         P=0.500          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.374N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/10 (20%)       2/10 (20%)       2/10 (20%)       0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          2/10.00          2/10.00          2/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             20.0%            20.0%            20.0%            0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        2/10 (20%)       2/10 (20%)       2/10 (20%)       0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              94 (T)           94 (T)           94 (T)           ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.156N         P=0.234          P=0.234          P=0.234          (e)              (e)             | 
|POLY 3             |        P=0.153N         P=0.227          P=0.227          P=0.227          (e)              (e)             | 
|POLY 1.5           |        P=0.153N         P=0.227          P=0.227          P=0.227          (e)              (e)             | 
|POLY 6             |        P=0.153N         P=0.227          P=0.227          P=0.227          (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              P=0.234          P=0.234          P=0.234          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.154N         P=0.237          P=0.237          P=0.237          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.228N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       2/10 (20%)       2/10 (20%)       2/10 (20%)       0/10 (0%)        1/10 (10%)      | 
|POLY-3 RATE (b)    |        1/10.00          2/10.00          2/10.00          2/10.00          0/10.00          1/9.00          | 
|POLY-3 PERCENT (g) |        10.0%            20.0%            20.0%            20.0%            0.0%             11.1%           | 
|TERMINAL (d)       |        1/10 (10%)       2/10 (20%)       2/10 (20%)       2/10 (20%)       0/10 (0%)        1/9 (11%)       | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.340N         P=0.500          P=0.500          P=0.500          P=0.500N         P=0.743         | 
|POLY 3             |        P=0.328N         P=0.500          P=0.500          P=0.500          P=0.500N         P=0.737         | 
|POLY 1.5           |        P=0.328N         P=0.500          P=0.500          P=0.500          P=0.500N         P=0.738         | 
|POLY 6             |        P=0.328N         P=0.500          P=0.500          P=0.500          P=0.500N         P=0.737         | 
|LOGISTIC REGRESSION|        P=0.338N         P=0.500          P=0.500          P=0.500          (e)              P=0.749         | 
|COCH-ARM / FISHERS |        P=0.306N         P=0.500          P=0.500          P=0.500          P=0.500N         P=0.763N        | 
|ORDER RESTRICTED   |        P=0.418N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          9/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             90.0%            100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)       10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          1/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             10.0%            100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              94 (T)           9               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001N**      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001N**      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.500          (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 10      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001N**       (e)              (e)              (e)              P<0.001N**       P<0.001 **      | 
|POLY 1.5           |        P<0.001N**       (e)              (e)              (e)              P<0.001N**       P<0.001 **      | 
|POLY 6             |        P<0.001N**       (e)              (e)              (e)              P<0.001N**       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              9               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001N**       (e)              (e)              (e)              (e)              P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       (e)              (e)              (e)              (e)              P<0.001N**      | 
|POLY 6             |        P<0.001N**       (e)              (e)              (e)              (e)              P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 11      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          6/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             60.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.009 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.009 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.005 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.00          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 12      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Oval Cell                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          9/9.00          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 13      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Periportal                                                                                                                | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Periportal                                                                                                                | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          9/9.00          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 14      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/10 (60%)       0/10 (0%)        5/10 (50%)       4/10 (40%)       2/10 (20%)       8/10 (80%)      | 
|POLY-3 RATE (b)    |        6/10.00          0/10.00          5/10.00          4/10.00          2/10.00          8/10.00         | 
|POLY-3 PERCENT (g) |        60.0%            0.0%             50.0%            40.0%            20.0%            80.0%           | 
|TERMINAL (d)       |        6/10 (60%)       0/10 (0%)        5/10 (50%)       4/10 (40%)       2/10 (20%)       8/10 (80%)      | 
|FIRST INCIDENCE    |        94 (T)           ---              94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.041 *        P=0.009N**       P=0.500N         P=0.331N         P=0.091N         P=0.317         | 
|POLY 3             |        P=0.025 *        P<0.001N**       P=0.500N         P=0.333N         P=0.077N         P=0.318         | 
|POLY 1.5           |        P=0.025 *        P<0.001N**       P=0.500N         P=0.333N         P=0.077N         P=0.318         | 
|POLY 6             |        P=0.025 *        P<0.001N**       P=0.500N         P=0.333N         P=0.077N         P=0.318         | 
|LOGISTIC REGRESSION|        P=0.041 *        (e)              P=0.500N         P=0.331N         P=0.091N         P=0.317         | 
|COCH-ARM / FISHERS |        P=0.039 *        P=0.005N**       P=0.500N         P=0.328N         P=0.085N         P=0.314         | 
|ORDER RESTRICTED   |        P=0.008 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/10 (0%)        0/10 (0%)        2/10 (20%)       2/10 (20%)       6/10 (60%)      | 
|POLY-3 RATE (b)    |        1/10.00          0/10.00          0/10.00          2/10.00          2/10.00          6/9.00          | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             20.0%            20.0%            66.7%           | 
|TERMINAL (d)       |        1/10 (10%)       0/10 (0%)        0/10 (0%)        2/10 (20%)       2/10 (20%)       6/9 (67%)       | 
|FIRST INCIDENCE    |        94 (T)           ---              ---              94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500N         P=0.500N         P=0.500          P=0.500          P=0.021 *       | 
|POLY 3             |        P<0.001 **       P=0.500N         P=0.500N         P=0.500          P=0.500          P=0.008 **      | 
|POLY 1.5           |        P<0.001 **       P=0.500N         P=0.500N         P=0.500          P=0.500          P=0.008 **      | 
|POLY 6             |        P<0.001 **       P=0.500N         P=0.500N         P=0.500          P=0.500          P=0.008 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P=0.500          P=0.500          P=0.021 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.500N         P=0.500          P=0.500          P=0.029 *       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 15      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Interstitium                                                                                                               | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/10 (70%)       0/10 (0%)        0/10 (0%)        1/10 (10%)       2/10 (20%)       1/10 (10%)      | 
|POLY-3 RATE (b)    |        7/10.00          0/10.00          0/10.00          1/10.00          2/10.00          1/10.00         | 
|POLY-3 PERCENT (g) |        70.0%            0.0%             0.0%             10.0%            20.0%            10.0%           | 
|TERMINAL (d)       |        7/10 (70%)       0/10 (0%)        0/10 (0%)        1/10 (10%)       2/10 (20%)       1/10 (10%)      | 
|FIRST INCIDENCE    |        94 (T)           ---              ---              94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.155N         P=0.003N**       P=0.003N**       P=0.013N*        P=0.040N*        P=0.013N*       | 
|POLY 3             |        P=0.107N         P<0.001N**       P<0.001N**       P=0.003N**       P=0.024N*        P=0.003N**      | 
|POLY 1.5           |        P=0.107N         P<0.001N**       P<0.001N**       P=0.003N**       P=0.024N*        P=0.003N**      | 
|POLY 6             |        P=0.107N         P<0.001N**       P<0.001N**       P=0.003N**       P=0.024N*        P=0.003N**      | 
|LOGISTIC REGRESSION|        P=0.155N         (e)              (e)              P=0.013N*        P=0.040N*        P=0.013N*       | 
|COCH-ARM / FISHERS |        P=0.153N         P=0.002N**       P=0.002N**       P=0.010N*        P=0.035N*        P=0.010N*       | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Interstitium                                                                                                               | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/10 (40%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        4/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.00          | 
|POLY-3 PERCENT (g) |        40.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        4/10 (40%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        94 (T)           ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.063N         P=0.051N         P=0.051N         P=0.051N         P=0.051N         P=0.063N        | 
|POLY 3             |        P=0.030N*        P=0.033N*        P=0.033N*        P=0.033N*        P=0.033N*        P=0.045N*       | 
|POLY 1.5           |        P=0.030N*        P=0.033N*        P=0.033N*        P=0.033N*        P=0.033N*        P=0.045N*       | 
|POLY 6             |        P=0.030N*        P=0.033N*        P=0.033N*        P=0.033N*        P=0.033N*        P=0.045N*       | 
|LOGISTIC REGRESSION|        P=0.063N         (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.058N         P=0.043N*        P=0.043N*        P=0.043N*        P=0.043N*        P=0.043N*       | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 16      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       2/10 (20%)       2/10 (20%)       2/10 (20%)       3/10 (30%)       6/10 (60%)      | 
|POLY-3 RATE (b)    |        1/10.00          2/10.00          2/10.00          2/10.00          3/10.00          6/9.00          | 
|POLY-3 PERCENT (g) |        10.0%            20.0%            20.0%            20.0%            30.0%            66.7%           | 
|TERMINAL (d)       |        1/10 (10%)       2/10 (20%)       2/10 (20%)       2/10 (20%)       3/10 (30%)       6/9 (67%)       | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       P=0.500          P=0.500          P=0.500          P=0.293          P=0.021 *       | 
|POLY 3             |        P=0.003 **       P=0.500          P=0.500          P=0.500          P=0.292          P=0.008 **      | 
|POLY 1.5           |        P=0.003 **       P=0.500          P=0.500          P=0.500          P=0.292          P=0.008 **      | 
|POLY 6             |        P=0.003 **       P=0.500          P=0.500          P=0.500          P=0.292          P=0.008 **      | 
|LOGISTIC REGRESSION|        P=0.003 **       P=0.500          P=0.500          P=0.500          P=0.293          P=0.021 *       | 
|COCH-ARM / FISHERS |        P=0.006 **       P=0.500          P=0.500          P=0.500          P=0.291          P=0.029 *       | 
|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 17      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/0.00           2/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             20.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.138          (e)              (e)              (e)              (e)              P=0.234         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.227         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.227         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.227         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.234         | 
|COCH-ARM / FISHERS |        P=0.132          (e)              (e)              (e)              (e)              P=0.237         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 18      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/10 (50%)       3/10 (30%)       5/10 (50%)       2/10 (20%)       3/10 (30%)       9/10 (90%)      | 
|POLY-3 RATE (b)    |        5/10.00          3/10.00          5/10.00          2/10.00          3/10.00          9/10.00         | 
|POLY-3 PERCENT (g) |        50.0%            30.0%            50.0%            20.0%            30.0%            90.0%           | 
|TERMINAL (d)       |        5/10 (50%)       3/10 (30%)       5/10 (50%)       2/10 (20%)       3/10 (30%)       9/10 (90%)      | 
|FIRST INCIDENCE    |        94 (T)           94 (T)           94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.016 *        P=0.328N         P=0.669          P=0.180N         P=0.328N         P=0.077         | 
|POLY 3             |        P=0.011 *        P=0.329N         P=0.664          P=0.174N         P=0.329N         P=0.061         | 
|POLY 1.5           |        P=0.011 *        P=0.329N         P=0.664          P=0.174N         P=0.329N         P=0.061         | 
|POLY 6             |        P=0.011 *        P=0.329N         P=0.664          P=0.174N         P=0.329N         P=0.061         | 
|LOGISTIC REGRESSION|        P=0.016 *        P=0.328N         P=0.669          P=0.180N         P=0.328N         P=0.077         | 
|COCH-ARM / FISHERS |        P=0.016 *        P=0.325N         P=0.672N         P=0.175N         P=0.325N         P=0.070         | 
|ORDER RESTRICTED   |        P=0.007 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Glandular                                                                                                               | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        3/10 (30%)       2/10 (20%)       2/10 (20%)       6/10 (60%)       7/10 (70%)      | 
|POLY-3 RATE (b)    |        0/10.00          3/10.00          2/10.00          2/10.00          6/10.00          7/9.00          | 
|POLY-3 PERCENT (g) |        0.0%             30.0%            20.0%            20.0%            60.0%            77.8%           | 
|TERMINAL (d)       |        0/10 (0%)        3/10 (30%)       2/10 (20%)       2/10 (20%)       6/10 (60%)       7/9 (78%)       | 
|FIRST INCIDENCE    |        ---              94 (T)           94 (T)           94 (T)           94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.111          P=0.234          P=0.234          P=0.009 **       P=0.002 **      | 
|POLY 3             |        P<0.001 **       P=0.095          P=0.227          P=0.227          P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.095          P=0.227          P=0.227          P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.095          P=0.227          P=0.227          P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P=0.111          P=0.234          P=0.234          P=0.009 **       P=0.002 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.105          P=0.237          P=0.237          P=0.005 **       P=0.002 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 19      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/2 (100%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          2/2.00           0/0.00           0/0.00           0/0.00           0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             100.0%           0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        2/2 (100%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              94 (T)           ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.211N         P=0.010 *        (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              P=0.015 *        (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              P=0.015 *        (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              P=0.015 *        (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              P=0.010 *        (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.206N         P=0.015 *        (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 20      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/10 (0%)        1/10 (10%)       1/10 (10%)      | 
|POLY-3 RATE (b)    |        2/10.00          0/0.00           0/0.00           0/10.00          1/10.00          1/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             10.0%            10.0%           | 
|TERMINAL (d)       |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/10 (0%)        1/10 (10%)       1/10 (10%)      | 
|FIRST INCIDENCE    |        94 (T)           ---              ---              ---              94 (T)           94 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.500N         P=1.000N         P=1.000N         P=0.234N         P=0.500N         P=0.500N        | 
|POLY 3             |        (e)              (e)              (e)              P=0.227N         P=0.500N         P=0.500N        | 
|POLY 1.5           |        (e)              (e)              (e)              P=0.227N         P=0.500N         P=0.500N        | 
|POLY 6             |        (e)              (e)              (e)              P=0.227N         P=0.500N         P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.500N         (e)              (e)              (e)              P=0.500N         P=0.500N        | 
|COCH-ARM / FISHERS |        P=0.500N         P=1.000          P=1.000          P=0.237N         P=0.500N         P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        1/10.00          0/0.00           0/0.00           0/0.00           0/10.00          0/9.00          | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        94 (T)           ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.282N         P=1.000          P=1.000          P=1.000          P=0.500N         P=0.521N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.500N         P=0.521N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.500N         P=0.520N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.500N         P=0.521N        | 
|LOGISTIC REGRESSION|        P=0.282N         (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.267N         P=1.000          P=1.000          P=1.000          P=0.500N         P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99020 TEST: 03                                            Page 21      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                         PULEGONE  
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          9.375            18.75            37.5             75               150             | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG            MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        2/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.00          | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        2/10 (20%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        94 (T)           ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.213N         P=0.234N         P=0.234N         P=0.234N         P=0.234N         P=0.257N        | 
|POLY 3             |        P=0.183N         P=0.227N         P=0.227N         P=0.227N         P=0.227N         P=0.252N        | 
|POLY 1.5           |        P=0.183N         P=0.227N         P=0.227N         P=0.227N         P=0.227N         P=0.251N        | 
|POLY 6             |        P=0.183N         P=0.227N         P=0.227N         P=0.227N         P=0.227N         P=0.252N        | 
|LOGISTIC REGRESSION|        P=0.213N         (e)              (e)              (e)              (e)              P=0.251N        | 
|COCH-ARM / FISHERS |        P=0.203N         P=0.237N         P=0.237N         P=0.237N         P=0.237N         P=0.237N        | 
|ORDER RESTRICTED   |        P=0.009N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
                                                                                                                                   
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).