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NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [2-, 11-, and 30-fold the maximum recommended human dose (MRHD) of 2 mg/week, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (1-, 2-, and 7-fold MRHD) were administered to the females

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The study was a randomized, double-blind trial that analyzed 156 patients treated with dopaminergic therapy

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