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FDAs Clinical Pharmacology team disagreed, concluding the reductions "could pose a clinically significant risk of loss of efficacy of contraception and unintended pregnancy" which is the basis for the backup-contraception guidance in ref
Monitor symptoms closely for 37 days after each administration
Subcutaneous research protocols have not identified dose-limiting toxicity
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Epilepsy Behav
Presented for research literature review only Dhar K et al
