National Toxicology Program

National Toxicology Program
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TDMS Study 05099-98 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: SOUTHERN RESEARCH INST                             SALICYLAZOSULFAPYRIDINE                                DATE: 05/10/95       
EXPERIMENT: 05099 TEST: 98                                                                                     TIME: 15:32:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: DR J. HEATH                                                                                       CAS: 599-79-1        
                                           05099/07 -VS- 05099/09 COMPARISON 



                                                    RATS(FISCHER344)
                                              ----------------------------
             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 NUMBER OF ANIMALS NECROPSIED.
                                                                    

                                                    ----------------

                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: SOUTHERN RESEARCH INST                             SALICYLAZOSULFAPYRIDINE                                DATE: 05/10/95       
EXPERIMENT: 05099 TEST: 98                                                                                     TIME: 15:32:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: DR J. HEATH                                                                                       CAS: 599-79-1        




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                    IN THE ANALYSIS OF THE STUDY OF SALICYLAZOSULFAPYRIDINE

              ====================================================================================================

                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------

                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
                             Pancreas                      Adenoma
                                                           Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Skin                          Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Testes                        Adenoma
                             Thyroid Gland: C-Cell         Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma or Adenoma

              ====================================================================================================
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Benign                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        15/50 (30%)          8/50 (16%)               |
|ADJUSTED (b)           |         38.2%               22.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |        11/35 (31%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          653                 700                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.371N                 |
|INCIDENTAL TUMOR       |                             P=0.152N                 |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.077N                 |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Malignant                                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)                |
|ADJUSTED (b)           |          0.0%                6.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         0/35 (0%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |           (e)                 (e)                    |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.247                  |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        16/50 (32%)          9/50 (18%)               |
|ADJUSTED (b)           |         39.8%               25.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |        11/35 (31%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          653                 700                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.255N                 |
|INCIDENTAL TUMOR       |                             P=0.058N                 |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.083N                 |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/50 (2%)           3/50 (6%)                |
|ADJUSTED (b)           |          2.5%                9.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         0/35 (0%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          684                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.510N                 |
|INCIDENTAL TUMOR       |                             P=0.429N                 |
|LOGISTIC REGRESSION    |                             P=0.503N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.309                  |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Carcinoma                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           0/50 (0%)                |
|ADJUSTED (b)           |          5.3%                0.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         1/35 (3%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          708                 ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.527N                 |
|INCIDENTAL TUMOR       |                             P=0.429N                 |
|LOGISTIC REGRESSION    |                             P=0.236N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.247N                 |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           3/50 (6%)                |
|ADJUSTED (b)           |          7.7%                9.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         1/35 (3%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          684                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.261N                 |
|INCIDENTAL TUMOR       |                             P=0.158N                 |
|LOGISTIC REGRESSION    |                             P=0.118N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.661N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)                |
|ADJUSTED (b)           |          5.3%                3.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         1/35 (3%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          684                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.510N                 |
|INCIDENTAL TUMOR       |                             P=0.429N                 |
|LOGISTIC REGRESSION    |                             P=0.235N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           1/50 (2%)                |
|ADJUSTED (b)           |          8.1%                3.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         2/35 (6%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          684                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.510N                 |
|INCIDENTAL TUMOR       |                             P=0.429N                 |
|LOGISTIC REGRESSION    |                             P=0.118N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.309N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)                |
|ADJUSTED (b)           |          5.6%                2.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         1/35 (3%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          726                 700                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.742                  |
|INCIDENTAL TUMOR       |                             P=0.684N                 |
|LOGISTIC REGRESSION    |                             P=0.499N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Adenoma                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           2/50 (4%)                |
|ADJUSTED (b)           |          5.7%                6.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         2/35 (6%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.235N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.691N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Fibroadenoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           2/50 (4%)                |
|ADJUSTED (b)           |          8.6%                6.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         3/35 (9%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.118N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
|                                                                              |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                    |
|     Papilloma Squamous or Papilloma                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)                |
|ADJUSTED (b)           |          0.0%                4.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         0/35 (0%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          ---                 627                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.247                  |
|INCIDENTAL TUMOR       |                             P=0.313                  |
|LOGISTIC REGRESSION    |                             P=0.212                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.247                  |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                    |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/50 (0%)           3/50 (6%)                |
|ADJUSTED (b)           |          0.0%                6.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         0/35 (0%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          ---                 627                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.130                  |
|INCIDENTAL TUMOR       |                             P=0.184                  |
|LOGISTIC REGRESSION    |                             P=0.099                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.121                  |
|==============================================================================|
|                                                                              |
|Pancreas                                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        12/50 (24%)          5/50 (10%)               |
|ADJUSTED (b)           |         31.4%               13.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         9/35 (26%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          684                 667                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.527N                 |
|INCIDENTAL TUMOR       |                             P=0.322N                 |
|LOGISTIC REGRESSION    |                             P=0.004N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.054N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Pancreas                                                                      |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        13/50 (26%)          5/50 (10%)               |
|ADJUSTED (b)           |         34.1%               13.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |        10/35 (29%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          684                 667                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.527N                 |
|INCIDENTAL TUMOR       |                             P=0.322N                 |
|LOGISTIC REGRESSION    |                             P=0.002N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.033N*                |
|==============================================================================|
|                                                                              |
|Pituitary Gland: Pars Distalis or Unspecified Site                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        14/50 (28%)         13/50 (26%)               |
|ADJUSTED (b)           |         34.3%               31.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         9/35 (26%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          473                 520                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.491                  |
|INCIDENTAL TUMOR       |                             P=0.614N                 |
|LOGISTIC REGRESSION    |                             P=0.045N*                |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE   9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Basal Cell Adenoma                                                       |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)                |
|ADJUSTED (b)           |          5.4%                3.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         1/35 (3%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          717                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.522N                 |
|INCIDENTAL TUMOR       |                             P=0.429N                 |
|LOGISTIC REGRESSION    |                             P=0.239N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Fibroma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           2/50 (4%)                |
|ADJUSTED (b)           |          5.7%                5.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         2/35 (6%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             597                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.513                  |
|INCIDENTAL TUMOR       |                             P=0.557                  |
|LOGISTIC REGRESSION    |                             P=0.504N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.691N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Keratoacanthoma                                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           1/50 (2%)                |
|ADJUSTED (b)           |          8.6%                3.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         3/35 (9%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.118N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.309N                 |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Trichoepithelioma                                                        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)                |
|ADJUSTED (b)           |          0.0%                6.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         0/35 (0%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |           (e)                 (e)                    |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.247                  |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           3/50 (6%)                |
|ADJUSTED (b)           |          5.4%                9.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         1/35 (3%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          717                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.522N                 |
|INCIDENTAL TUMOR       |                             P=0.429N                 |
|LOGISTIC REGRESSION    |                             P=0.239N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500                  |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,             |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         6/50 (12%)          4/50 (8%)                |
|ADJUSTED (b)           |         16.5%               12.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         5/35 (14%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          717                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.522N                 |
|INCIDENTAL TUMOR       |                             P=0.429N                 |
|LOGISTIC REGRESSION    |                             P=0.019N*                |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.370N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Testes                                                                        |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        45/50 (90%)         44/50 (88%)               |
|ADJUSTED (b)           |         97.8%               95.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |        34/35 (97%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          477                 520                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.400                  |
|INCIDENTAL TUMOR       |                             P=0.536N                 |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           4/49 (8%)                |
|ADJUSTED (b)           |          8.6%               12.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         3/35 (9%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.118N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.489                  |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Carcinoma                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           0/49 (0%)                |
|ADJUSTED (b)           |          5.7%                0.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         2/35 (6%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.235N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.253N                 |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/50 (10%)          4/49 (8%)                |
|ADJUSTED (b)           |         14.3%               12.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         5/35 (14%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.031N*                |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.513N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         4/50 (8%)           0/49 (0%)                |
|ADJUSTED (b)           |         11.4%                0.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         4/35 (11%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.060N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.061N                 |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/50 (10%)          0/49 (0%)                |
|ADJUSTED (b)           |         14.3%                0.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         5/35 (14%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.031N*                |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.030N*                |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|Tongue                                                                        |
|     Squamous Cell Carcinoma or Papilloma Squamous                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)                |
|ADJUSTED (b)           |          0.0%                4.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         0/35 (0%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          ---                 627                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.250                  |
|INCIDENTAL TUMOR       |                             P=0.313                  |
|LOGISTIC REGRESSION    |                             P=0.204                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.247                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                           |
|     or Undifferentiated                                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        13/50 (26%)         10/50 (20%)               |
|ADJUSTED (b)           |         32.0%               23.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         8/35 (23%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          477                 520                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.267                  |
|INCIDENTAL TUMOR       |                             P=0.441                  |
|LOGISTIC REGRESSION    |                             P=0.167N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.318N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Mesothelioma Benign, Malignant, NOS                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/50 (2%)           3/50 (6%)                |
|ADJUSTED (b)           |          2.9%                8.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |         1/35 (3%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          729 (T)             682                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.495                  |
|INCIDENTAL TUMOR       |                             P=0.571                  |
|LOGISTIC REGRESSION    |                             P=0.760N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.309                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        49/50 (98%)         48/50 (96%)               |
|ADJUSTED (b)           |        100.0%              100.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |        35/35 (100%)         0/0                      |
|FIRST INCIDENCE (DAYS) |          473                 520                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.485                  |
|INCIDENTAL TUMOR       |                             P=0.157N                 |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             0 MG/KG                 |
|                       |          AD LIB              RTD                     |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        23/50 (46%)         17/50 (34%)               |
|ADJUSTED (b)           |         49.9%               38.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |        12/35 (34%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          477                 520                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.556                  |
|INCIDENTAL TUMOR       |                             P=0.205N                 |
|LOGISTIC REGRESSION    |                             P=0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.154N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        49/50 (98%)         48/50 (96%)               |
|ADJUSTED (b)           |        100.0%              100.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)                |
|TERMINAL (d)           |        35/35 (100%)         0/0                      |
|FIRST INCIDENCE (DAYS) |          473                 520                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.485                  |
|INCIDENTAL TUMOR       |                             P=0.157N                 |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05099 TEST: 98                                                 PAGE  18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 105 WEEKS
                                                                           

 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   730
          Female interim sacrifices(days):
 (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.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's 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. 
 (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).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.