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Accordingly, we believe that this alternative fixed-list approach would reduce the number of ASM participants over the ASM test period and the magnitude of this potential decrease could undermine the reliability of the model test

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“Intravenous infusion of up to 20 mg of BPC-157 in 2 healthy adults showed no adverse effects and was well-tolerated.” — Lee & Burgess, Alternative Therapies in Health and Medicine, 2025 Limitations : Only 2 participants Very short observation period No long-term follow-up No efficacy endpoints What These Studies Tell Us—And What They Don’t What We Can Reasonably Conclude Short-term tolerance appears acceptable : Across all three studies (roughly 30 participants total), no adverse events were reported