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Preclinical safety data:  Carcinogenesis, Mutagenesis, Reproductive and Developmental Toxicity and Impairment of Fertility: Carcinogenesis: The 2-year carcinogenicity studies were conducted in mice and rats given oral valproate doses of approximately 80 and 160 mg/kg/day (which are the maximum tolerated doses in these species but less than the maximum recommended human dose based on body surface area)

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