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and, taking their submissions into consideration to revise the draft, followed by review by the Agencys Health, Medical and Research (HMR) Committee.

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Impairment of fertility: In sub-chronic/chronic toxicity studies, testicular degeneration/atrophy or spermatogenesis abnormalities and a decrease in testes weight were reported in adult rats and dogs after oral administration starting at doses of 1250 mg/kg/day and 150 mg/kg/day, respectively