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Study 1 – Summary of the contemporary historical control data for interstitial cell tumors in the testes of rats in chronic toxicity studies.
| Study 1 | Study 2 | Study 3 | Study 4 | Study 5 | Range | |
|---|---|---|---|---|---|---|
| Number of control animals/total number examined (% per study) | ||||||
| Terminal sacrifice | 4/65 (6.2) | 3/11 (27.3) | 3/26 (11.5) | 3/24 (12.5) | 3/40 (7.5) | 6.2–27.3% |
| All animals | 4/116 (3.4) | 5/75 (6.7) | 4/113 (3.5) | 6/113 (5.3) | 5/118 (4.2) | 3.4–6.7% |
