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The sample size was calculated to provide at least 90% power for showing bioequivalence between the 1G and 2G formulations for all three dose groups, based on the standard acceptance limits (0.80001.2500) to ensure sufficient power to confirm bioequivalence in accordance with the EMA, FDA and PMDA guidelines

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Food and Drug Administration EGRIFTA (tesamorelin for injection) prescribing information / label

GI side effects parallel those of other incretin therapies: nausea, diarrhea, and constipation during dose escalation