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Step 4 Public Comment Period: Any proposed rule is subject to a federal public comment period before it becomes final

Key implications Study protocols must justify the relevance of each patient-reported outcome (PRO)

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From available case reports, compounding pharmacy data, and practitioner experience, the following have been observed: BPC-157 Reported Side Effects Nausea and gastrointestinal discomfort (especially with oral administration) Dizziness or light-headedness Flushing or warmth at injection sites Headache Fatigue or somnolence in some users TB-500 Reported Side Effects Injection site reactions (redness, mild pain, swelling) Transient fatigue or lethargy following administration Headache Possible flu-like symptoms in a minority of users Critical Risk Note: Because neither peptide has undergone full clinical trial evaluation in humans, the complete adverse event profile is unknown