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The FDA sets out its position in the list of bulk drug substances nominated for use in compounding under section 503A, where CJC-1295, ipamorelin, BPC-157, Semax, Epithalon and MOTS-c are all placed in Category 2 for significant safety risks

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Overall, the heterogeneity analysis (see supplementary material) indicated the study design and patient characteristics across the 12 included trials [19, 30, 35–37, 39, 41–43, 47, 48, 51] were sufficiently aligned with the PIONEER 8 trial and generalisable to the population of interest to be combined in the analyses

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