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Federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to the FDA, so underreporting is likely

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At the 12 mg dose level, here is what clinical trials reported: Nausea: 43.2% of participants (versus 10.7% on placebo) Diarrhea: 33.1% of participants (versus 13.4% on placebo) Constipation: 25.0% of participants (versus 8.7% on placebo) Vomiting: 20.9% of participants These percentages tell an important story

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