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Revised diagnostic criteria and classification for the ALPS syndrome were established in 2009 at a US National Institutes of Health International Workshop

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That recommendation came despite FDA staff concluding that: 🔹 BPC-157 is not adequately characterized, 🔹 Evidence is insufficient to establish effectiveness, 🔹 Clinical safety data cannot define a reliable safety profile, 🔹 Impurities and peptide aggregation may create immunogenicity risks