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Overall, galcanezumab was safe and well tolerated in the clinical trials described above

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For increased patient safety in APAP consumption, the FDA has worked to mitigate APAP hepatotoxicity by legislating regulations to limit prescription combination drug products to have no more than 325 mg of APAP per dosage unit and have urged healthcare providers to cease prescribing combination drug products with more than 325 mg of APAP per tablet