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While research shows some benefits (for example improved sleep efficiency, reduced sleep latency) in controlled settings, there are still questions around long-term safety, especially in healthy subjects or non-clinical contexts

FDA reviewers, applying the statutory framework under 21 CFR 216.23(c), identified only one human study for BPC-157's proposed indication of ulcerative colitis: a decades-old meeting abstract that was never published as a peer-reviewed trial and that used an oral route of administration not the injectable or subcutaneous routes that wellness clinics commonly use

PMID: 32083078

A 26-week result and a 48-week result are not the same measurement