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The agency said such discrepancies raise concerns about the safety of the trial subjects and the reliability of the trial data.

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In the Lancet 2021 Phase 2 trial at 4.5 mg/week, nausea occurred in 47% of participants, injection-site reactions in 43%, constipation in 21%, and vomiting in 8%

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This is the recommended starting formulation for all new patients

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The overall discontinuation rate due to adverse events was approximately 10%, which compares favorably to most compounds in this class

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