NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                          TRANSGENIC MODEL EVALUATION II (GLYCIDOL)                      DATE: 03/31/04       
EXPERIMENT: 99035 TEST: 01                                                                                     TIME: 12:56:50       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: C99035       
PATHOLOGIST: MISSING                                                                                           CAS: 556-52-5        
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                                                              FINAL #1                                                              
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                          TRANSGENIC MODEL EVALUATION II (GLYCIDOL)                      DATE: 03/31/04       
EXPERIMENT: 99035 TEST: 01                                                                                     TIME: 12:56:50       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: C99035       
PATHOLOGIST: MISSING                                                                                           CAS: 556-52-5        
Mice(P16(INK4A)/(+/-) (C57BL/6))                                                                                                    
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Bone Marrow                                                                        
                                                 Brain                                                                              
                                                 Lung                                                                               
                                                 Spleen                                                                             
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                          TRANSGENIC MODEL EVALUATION II (GLYCIDOL)                      DATE: 03/31/04       
EXPERIMENT: 99035 TEST: 01                                                                                     TIME: 12:56:50       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: C99035       
PATHOLOGIST: MISSING                                                                                           CAS: 556-52-5        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF        TRANSGENIC MODEL EVALUATION II (GLY                                                                       
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Lung                                   Alveolar/Bronchiolar Adenoma                                                                 
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
All Organs                             Histiocytic Sarcoma                                                                          
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Lung                                   Alveolar/Bronchiolar Adenoma                                                                 
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
Stomach, Forestomach                   Squamous Cell Papilloma                                                                      
All Organs                             Histiocytic Sarcoma                                                                          
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 1       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))        -         TRANSGENIC MODEL EVALUATION II (GLY     
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/15 (7%)        0/15 (0%)        2/15 (13%)       7/15 (47%)       3/15 (20%)                       | 
|POLY-3 RATE (b)    |        1/13.95          0/14.74          2/13.80          7/14.37          3/11.42                          | 
|POLY-3 PERCENT (g) |        7.2%             0.0%             14.5%            48.7%            26.3%                            | 
|TERMINAL (d)       |        1/13 (8%)        0/14 (0%)        2/13 (15%)       7/14 (50%)       3/7 (43%)                        | 
|FIRST INCIDENCE    |        280 (T)          ---              280 (T)          280 (T)          280 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       P=0.485N         P=0.500          P=0.026 *        P=0.104                          | 
|POLY 3             |        P=0.009 **       P=0.489N         P=0.496          P=0.013 *        P=0.223                          | 
|POLY 1.5           |        P=0.019 *        P=0.493N         P=0.496          P=0.013 *        P=0.255                          | 
|POLY 6             |        P=0.004 **       P=0.485N         P=0.499          P=0.014 *        P=0.186                          | 
|LOGISTIC REGRESSION|        P=0.003 **       (e)              P=0.500          P=0.026 *        P=0.104                          | 
|COCH-ARM / FISHERS |        P=0.053          P=0.500N         P=0.500          P=0.018 *        P=0.299                          | 
|ORDER RESTRICTED   |        P=0.014 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        1/15 (7%)        0/15 (0%)        1/15 (7%)        4/15 (27%)                       | 
|POLY-3 RATE (b)    |        0/13.88          1/14.62          0/14.15          1/14.62          4/13.34                          | 
|POLY-3 PERCENT (g) |        0.0%             6.8%             0.0%             6.8%             30.0%                            | 
|TERMINAL (d)       |        0/13 (0%)        1/14 (7%)        0/12 (0%)        1/14 (7%)        2/9 (22%)                        | 
|FIRST INCIDENCE    |        ---              281 (T)          ---              281 (T)          208                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       P=0.515          (e)              P=0.515          P=0.038 *                        | 
|POLY 3             |        P=0.003 **       P=0.510          (e)              P=0.510          P=0.039 *                        | 
|POLY 1.5           |        P=0.004 **       P=0.510          (e)              P=0.510          P=0.042 *                        | 
|POLY 6             |        P=0.003 **       P=0.509          (e)              P=0.509          P=0.037 *                        | 
|LOGISTIC REGRESSION|        P=0.007 **       P=0.515          (e)              P=0.515          P=0.056                          | 
|COCH-ARM / FISHERS |        P=0.005 **       P=0.500          (e)              P=0.500          P=0.050                          | 
|ORDER RESTRICTED   |        P=0.003 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 2       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -         TRANSGENIC MODEL EVALUATION II (GLY      
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/15 (13%)       1/15 (7%)        1/15 (7%)        3/15 (20%)       0/15 (0%)                        | 
|POLY-3 RATE (b)    |        2/13.95          1/14.74          1/13.80          3/14.37          0/11.42                          | 
|POLY-3 PERCENT (g) |        14.3%            6.8%             7.2%             20.9%            0.0%                             | 
|TERMINAL (d)       |        2/13 (15%)       1/14 (7%)        1/13 (8%)        3/14 (21%)       0/7 (0%)                         | 
|FIRST INCIDENCE    |        280 (T)          280 (T)          280 (T)          280 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.471N         P=0.473N         P=0.500N         P=0.536          P=0.380N                         | 
|POLY 3             |        P=0.385N         P=0.480N         P=0.504N         P=0.514          P=0.279N                         | 
|POLY 1.5           |        P=0.342N         P=0.488N         P=0.504N         P=0.508          P=0.257N                         | 
|POLY 6             |        P=0.439N         P=0.473N         P=0.501N         P=0.523          P=0.310N                         | 
|LOGISTIC REGRESSION|        P=0.471N         P=0.473N         P=0.500N         P=0.536          (e)                              | 
|COCH-ARM / FISHERS |        P=0.287N         P=0.500N         P=0.500N         P=0.500          P=0.241N                         | 
|ORDER RESTRICTED   |        P=0.220N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        0/15 (0%)        0/15 (0%)        1/15 (7%)        0/15 (0%)                        | 
|POLY-3 RATE (b)    |        0/13.88          0/14.62          0/14.15          1/14.62          0/12.41                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             6.8%             0.0%                             | 
|TERMINAL (d)       |        0/13 (0%)        0/14 (0%)        0/12 (0%)        1/14 (7%)        0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              281 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.603          (e)              (e)              P=0.515          (e)                              | 
|POLY 3             |        P=0.560          (e)              (e)              P=0.510          (e)                              | 
|POLY 1.5           |        P=0.591          (e)              (e)              P=0.510          (e)                              | 
|POLY 6             |        P=0.529          (e)              (e)              P=0.509          (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.515          (e)                              | 
|COCH-ARM / FISHERS |        P=0.639          (e)              (e)              P=0.500          (e)                              | 
|ORDER RESTRICTED   |        P=0.388          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 3       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -         TRANSGENIC MODEL EVALUATION II (GLY      
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/15 (20%)       1/15 (7%)        3/15 (20%)       8/15 (53%)       3/15 (20%)                       | 
|POLY-3 RATE (b)    |        3/13.95          1/14.74          3/13.80          8/14.37          3/11.42                          | 
|POLY-3 PERCENT (g) |        21.5%            6.8%             21.7%            55.7%            26.3%                            | 
|TERMINAL (d)       |        3/13 (23%)       1/14 (7%)        3/13 (23%)       8/14 (57%)       3/7 (43%)                        | 
|FIRST INCIDENCE    |        280 (T)          280 (T)          280 (T)          280 (T)          280 (T)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.032 *        P=0.271N         P=0.676          P=0.084          P=0.345                          | 
|POLY 3             |        P=0.093          P=0.277N         P=0.668          P=0.063          P=0.573                          | 
|POLY 1.5           |        P=0.146          P=0.285N         P=0.666          P=0.061          P=0.618                          | 
|POLY 6             |        P=0.048 *        P=0.269N         P=0.672          P=0.067          P=0.509                          | 
|LOGISTIC REGRESSION|        P=0.032 *        P=0.271N         P=0.676          P=0.084          P=0.345                          | 
|COCH-ARM / FISHERS |        P=0.252          P=0.299N         P=0.674N         P=0.064          P=0.674N                         | 
|ORDER RESTRICTED   |        P=0.078          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        1/15 (7%)        0/15 (0%)        2/15 (13%)       4/15 (27%)                       | 
|POLY-3 RATE (b)    |        0/13.88          1/14.62          0/14.15          2/14.62          4/13.34                          | 
|POLY-3 PERCENT (g) |        0.0%             6.8%             0.0%             13.7%            30.0%                            | 
|TERMINAL (d)       |        0/13 (0%)        1/14 (7%)        0/12 (0%)        2/14 (14%)       2/9 (22%)                        | 
|FIRST INCIDENCE    |        ---              281 (T)          ---              281 (T)          208                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       P=0.515          (e)              P=0.252          P=0.038 *                        | 
|POLY 3             |        P=0.004 **       P=0.510          (e)              P=0.243          P=0.039 *                        | 
|POLY 1.5           |        P=0.004 **       P=0.510          (e)              P=0.243          P=0.042 *                        | 
|POLY 6             |        P=0.004 **       P=0.509          (e)              P=0.242          P=0.037 *                        | 
|LOGISTIC REGRESSION|        P=0.007 **       P=0.515          (e)              P=0.252          P=0.056                          | 
|COCH-ARM / FISHERS |        P=0.006 **       P=0.500          (e)              P=0.241          P=0.050                          | 
|ORDER RESTRICTED   |        P=0.006 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 4       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -         TRANSGENIC MODEL EVALUATION II (GLY      
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        0/15 (0%)        0/15 (0%)        0/15 (0%)        1/15 (7%)                        | 
|POLY-3 RATE (b)    |        0/13.95          0/14.74          0/13.80          0/14.37          1/11.95                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             8.4%                             | 
|TERMINAL (d)       |        0/13 (0%)        0/14 (0%)        0/13 (0%)        0/14 (0%)        0/7 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              218                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.112          (e)              (e)              (e)              P=0.452                          | 
|POLY 3             |        P=0.127          (e)              (e)              (e)              P=0.469                          | 
|POLY 1.5           |        P=0.134          (e)              (e)              (e)              P=0.482                          | 
|POLY 6             |        P=0.119          (e)              (e)              (e)              P=0.452                          | 
|LOGISTIC REGRESSION|        P=0.229          (e)              (e)              (e)              P=0.684                          | 
|COCH-ARM / FISHERS |        P=0.143          (e)              (e)              (e)              P=0.500                          | 
|ORDER RESTRICTED   |        P=0.065          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        0/15 (0%)        0/15 (0%)        1/15 (7%)        3/15 (20%)                       | 
|POLY-3 RATE (b)    |        0/13.88          0/14.62          0/14.15          1/14.62          3/12.46                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             6.8%             24.1%                            | 
|TERMINAL (d)       |        0/13 (0%)        0/14 (0%)        0/12 (0%)        1/14 (7%)        1/9 (11%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              281 (T)          278                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       (e)              (e)              P=0.515          P=0.081                          | 
|POLY 3             |        P=0.003 **       (e)              (e)              P=0.510          P=0.085                          | 
|POLY 1.5           |        P=0.004 **       (e)              (e)              P=0.510          P=0.094                          | 
|POLY 6             |        P=0.003 **       (e)              (e)              P=0.509          P=0.077                          | 
|LOGISTIC REGRESSION|        P=0.002 **       (e)              (e)              P=0.515          P=0.079                          | 
|COCH-ARM / FISHERS |        P=0.005 **       (e)              (e)              P=0.500          P=0.112                          | 
|ORDER RESTRICTED   |        P=0.006 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 5       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -         TRANSGENIC MODEL EVALUATION II (GLY      
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/15 (13%)       6/15 (40%)       9/15 (60%)       5/15 (33%)       11/15 (73%)                      | 
|POLY-3 RATE (b)    |        2/14.61          6/15.00          9/15.00          5/14.37          11/14.47                         | 
|POLY-3 PERCENT (g) |        13.7%            40.0%            60.0%            34.8%            76.0%                            | 
|TERMINAL (d)       |        1/13 (8%)        5/14 (36%)       7/13 (54%)       5/14 (36%)       4/7 (57%)                        | 
|FIRST INCIDENCE    |        196              253              146              280 (T)          181                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.150          P=0.021 *        P=0.231          P<0.001 **                       | 
|POLY 3             |        P=0.002 **       P=0.113          P=0.007 **       P=0.186          P<0.001 **                       | 
|POLY 1.5           |        P=0.003 **       P=0.109          P=0.007 **       P=0.189          P<0.001 **                       | 
|POLY 6             |        P=0.002 **       P=0.118          P=0.008 **       P=0.186          P<0.001 **                       | 
|LOGISTIC REGRESSION|        P=0.023 *        P=0.047 *        P=0.008 **       P=0.177          P=0.007 **                       | 
|COCH-ARM / FISHERS |        P=0.005 **       P=0.107          P=0.010 *        P=0.195          P<0.001 **                       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/15 (60%)       9/15 (60%)       12/15 (80%)      10/15 (67%)      13/15 (87%)                      | 
|POLY-3 RATE (b)    |        9/14.03          9/15.00          12/15.00         10/15.00         13/14.97                         | 
|POLY-3 PERCENT (g) |        64.2%            60.0%            80.0%            66.7%            86.9%                            | 
|TERMINAL (d)       |        8/13 (62%)       8/14 (57%)       9/12 (75%)       9/14 (64%)       8/9 (89%)                        | 
|FIRST INCIDENCE    |        267              239              232              239              133                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.009 **       P=0.550N         P=0.194          P=0.590          P=0.026 *                        | 
|POLY 3             |        P=0.102          P=0.558N         P=0.299          P=0.595          P=0.160                          | 
|POLY 1.5           |        P=0.099          P=0.571N         P=0.285          P=0.582          P=0.150                          | 
|POLY 6             |        P=0.101          P=0.556N         P=0.302          P=0.598          P=0.159                          | 
|LOGISTIC REGRESSION|        P=0.076          P=0.590N         P=0.245          P=0.568          P=0.099                          | 
|COCH-ARM / FISHERS |        P=0.076          P=0.645N         P=0.213          P=0.500          P=0.107                          | 
|ORDER RESTRICTED   |        P=0.115          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 6       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -         TRANSGENIC MODEL EVALUATION II (GLY      
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/15 (13%)       0/15 (0%)        0/15 (0%)        1/15 (7%)        0/15 (0%)                        | 
|POLY-3 RATE (b)    |        2/13.95          0/14.74          0/13.80          1/15.00          0/11.42                          | 
|POLY-3 PERCENT (g) |        14.3%            0.0%             0.0%             6.7%             0.0%                             | 
|TERMINAL (d)       |        2/13 (15%)       0/14 (0%)        0/13 (0%)        0/14 (0%)        0/7 (0%)                         | 
|FIRST INCIDENCE    |        280 (T)          ---              ---              201              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.327N         P=0.219N         P=0.235N         P=0.475N         P=0.380N                         | 
|POLY 3             |        P=0.287N         P=0.218N         P=0.233N         P=0.474N         P=0.279N                         | 
|POLY 1.5           |        P=0.279N         P=0.223N         P=0.234N         P=0.485N         P=0.257N                         | 
|POLY 6             |        P=0.292N         P=0.214N         P=0.231N         P=0.462N         P=0.310N                         | 
|LOGISTIC REGRESSION|        P=0.201N         (e)              (e)              P=0.543N         (e)                              | 
|COCH-ARM / FISHERS |        P=0.266N         P=0.241N         P=0.241N         P=0.500N         P=0.241N                         | 
|ORDER RESTRICTED   |        P=0.070N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        0/15 (0%)        0/15 (0%)        0/15 (0%)        0/15 (0%)                        | 
|POLY-3 RATE (b)    |        0/13.88          0/14.62          0/14.15          0/14.62          0/12.41                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/13 (0%)        0/14 (0%)        0/12 (0%)        0/14 (0%)        0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 7       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -         TRANSGENIC MODEL EVALUATION II (GLY      
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/15 (7%)        2/15 (13%)       2/15 (13%)       7/15 (47%)       4/15 (27%)                       | 
|POLY-3 RATE (b)    |        1/13.95          2/14.74          2/13.80          7/14.37          4/11.95                          | 
|POLY-3 PERCENT (g) |        7.2%             13.6%            14.5%            48.7%            33.5%                            | 
|TERMINAL (d)       |        1/13 (8%)        2/14 (14%)       2/13 (15%)       7/14 (50%)       3/7 (43%)                        | 
|FIRST INCIDENCE    |        280 (T)          280 (T)          280 (T)          280 (T)          218                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       P=0.527          P=0.500          P=0.026 *        P=0.050                          | 
|POLY 3             |        P=0.018 *        P=0.519          P=0.496          P=0.013 *        P=0.112                          | 
|POLY 1.5           |        P=0.028 *        P=0.512          P=0.496          P=0.013 *        P=0.132                          | 
|POLY 6             |        P=0.010 *        P=0.527          P=0.499          P=0.014 *        P=0.090                          | 
|LOGISTIC REGRESSION|        P=0.015 *        P=0.527          P=0.500          P=0.026 *        P=0.113                          | 
|COCH-ARM / FISHERS |        P=0.055          P=0.500          P=0.500          P=0.018 *        P=0.165                          | 
|ORDER RESTRICTED   |        P=0.025 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        1/15 (7%)        0/15 (0%)        2/15 (13%)       7/15 (47%)                       | 
|POLY-3 RATE (b)    |        0/13.88          1/14.62          0/14.15          2/14.62          7/13.40                          | 
|POLY-3 PERCENT (g) |        0.0%             6.8%             0.0%             13.7%            52.3%                            | 
|TERMINAL (d)       |        0/13 (0%)        1/14 (7%)        0/12 (0%)        2/14 (14%)       3/9 (33%)                        | 
|FIRST INCIDENCE    |        ---              281 (T)          ---              281 (T)          208                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.515          (e)              P=0.252          P=0.004 **                       | 
|POLY 3             |        P<0.001 **       P=0.510          (e)              P=0.243          P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       P=0.510          (e)              P=0.243          P<0.001 **                       | 
|POLY 6             |        P<0.001 **       P=0.509          (e)              P=0.242          P<0.001 **                       | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.515          (e)              P=0.252          P=0.004 **                       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          (e)              P=0.241          P=0.003 **                       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 8       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -         TRANSGENIC MODEL EVALUATION II (GLY      
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/15 (40%)       7/15 (47%)       10/15 (67%)      9/15 (60%)       11/15 (73%)                      | 
|POLY-3 RATE (b)    |        6/15.00          7/15.00          10/15.00         9/15.00          11/14.47                         | 
|POLY-3 PERCENT (g) |        40.0%            46.7%            66.7%            60.0%            76.0%                            | 
|TERMINAL (d)       |        4/13 (31%)       6/14 (43%)       8/13 (62%)       8/14 (57%)       4/7 (57%)                        | 
|FIRST INCIDENCE    |        196              253              146              201              181                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       P=0.561          P=0.180          P=0.315          P=0.023 *                        | 
|POLY 3             |        P=0.036 *        P=0.500          P=0.136          P=0.236          P=0.047 *                        | 
|POLY 1.5           |        P=0.041 *        P=0.500          P=0.136          P=0.236          P=0.054                          | 
|POLY 6             |        P=0.031 *        P=0.500          P=0.136          P=0.236          P=0.040 *                        | 
|LOGISTIC REGRESSION|        P=0.181          (e)              (e)              (e)              P=0.207                          | 
|COCH-ARM / FISHERS |        P=0.049 *        P=0.500          P=0.136          P=0.233          P=0.070                          | 
|ORDER RESTRICTED   |        P=0.033 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/15 (67%)      9/15 (60%)       12/15 (80%)      11/15 (73%)      14/15 (93%)                      | 
|POLY-3 RATE (b)    |        10/15.00         9/15.00          12/15.00         11/15.00         14/15.00                         | 
|POLY-3 PERCENT (g) |        66.7%            60.0%            80.0%            73.3%            93.3%                            | 
|TERMINAL (d)       |        8/13 (62%)       8/14 (57%)       9/12 (75%)       10/14 (71%)      8/9 (89%)                        | 
|FIRST INCIDENCE    |        83               239              232              239              133                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.006 **       P=0.420N         P=0.303          P=0.591          P=0.036 *                        | 
|POLY 3             |        P=0.037 *        P=0.500N         P=0.343          P=0.500          P=0.080                          | 
|POLY 1.5           |        P=0.037 *        P=0.500N         P=0.343          P=0.500          P=0.080                          | 
|POLY 6             |        P=0.037 *        P=0.500N         P=0.343          P=0.500          P=0.080                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.037 *        P=0.500N         P=0.341          P=0.500          P=0.084                          | 
|ORDER RESTRICTED   |        P=0.042 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/31/04                           EXPERIMENT: 99035 TEST: 01                                            Page 9       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -         TRANSGENIC MODEL EVALUATION II (GLY      
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/15 (47%)       8/15 (53%)       12/15 (80%)      12/15 (80%)      12/15 (80%)                      | 
|POLY-3 RATE (b)    |        7/15.00          8/15.00          12/15.00         12/15.00         12/14.47                         | 
|POLY-3 PERCENT (g) |        46.7%            53.3%            80.0%            80.0%            83.0%                            | 
|TERMINAL (d)       |        5/13 (39%)       7/14 (50%)       10/13 (77%)      11/14 (79%)      5/7 (71%)                        | 
|FIRST INCIDENCE    |        196              253              146              201              181                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.569          P=0.110          P=0.140          P=0.016 *                        | 
|POLY 3             |        P=0.018 *        P=0.500          P=0.059          P=0.059          P=0.039 *                        | 
|POLY 1.5           |        P=0.023 *        P=0.500          P=0.059          P=0.059          P=0.047 *                        | 
|POLY 6             |        P=0.014 *        P=0.500          P=0.059          P=0.059          P=0.032 *                        | 
|LOGISTIC REGRESSION|        P=0.086          (e)              (e)              (e)              P=0.160                          | 
|COCH-ARM / FISHERS |        P=0.033 *        P=0.500          P=0.064          P=0.064          P=0.064                          | 
|ORDER RESTRICTED   |        P=0.021 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          25 MG/KG         50 MG/KG         100              200                              | 
|                   |                                                           MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/15 (67%)      9/15 (60%)       12/15 (80%)      12/15 (80%)      14/15 (93%)                      | 
|POLY-3 RATE (b)    |        10/15.00         9/15.00          12/15.00         12/15.00         14/15.00                         | 
|POLY-3 PERCENT (g) |        66.7%            60.0%            80.0%            80.0%            93.3%                            | 
|TERMINAL (d)       |        8/13 (62%)       8/14 (57%)       9/12 (75%)       11/14 (79%)      8/9 (89%)                        | 
|FIRST INCIDENCE    |        83               239              232              239              133                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.004 **       P=0.420N         P=0.303          P=0.465          P=0.036 *                        | 
|POLY 3             |        P=0.027 *        P=0.500N         P=0.343          P=0.343          P=0.080                          | 
|POLY 1.5           |        P=0.027 *        P=0.500N         P=0.343          P=0.343          P=0.080                          | 
|POLY 6             |        P=0.027 *        P=0.500N         P=0.343          P=0.343          P=0.080                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.028 *        P=0.500N         P=0.341          P=0.341          P=0.084                          | 
|ORDER RESTRICTED   |        P=0.038 *        (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).