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[DOI: 10.1016/S0140-6736(03)13413-7] [DOI] [PMC free article] [PubMed] [Google Scholar] 29.Hwang DM, Chamberlain DW, Poutanen SM, Low DE, Asa SL, Butany J

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It bears repeating clearly: peptides such as BPC-157 and TB-500 are not approved for human use by the FDA or EMA, their long-term safety in humans is not established, and much of the evidence base comes from animal or preclinical studies rather than large human trials