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On this website, we consider an adverse event to tentatively be a side effect of the drug if it was reported in participants who received the study drug at least twice as often as in those who received placebo

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The Secretarys support does not itself add a substance to the 503A Bulks List, approve a drug, establish an indication, or resolve the scientific evidence

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If pregnancy occurs during treatment, the medication should be stopped immediately and healthcare providers notified