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Long-term safety data simply do not exist

For example, approved incretin-based medicines may have defined indications, product information, and coverage criteria

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In clinical trials, the most common observations were gastrointestinal effects: nausea (44.2% vs 17.4% placebo in STEP 1), diarrhea (30.0%), vomiting (24.8%), and constipation (24.2%)

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It must use bulk drug substances that comply with an applicable USP or NF monograph where one exists, that are manufactured by an FDA-registered establishment, and that are accompanied by valid certificates of analysis