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AOD9604 is not FDAapproved for any medical indication, and FDA advisory documents note concerns about immunogenicity, peptide-related impurities, and lack of sufficient safety and efficacy data
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Reported side effects are typically mildsuch as injection-site irritation, headache, or fatiguebut regulatory reviews highlight potential immunogenicity and uncertainties around long-term safety and product quality in compounded or nonapproved forms
all tests were two-tailed and = 0.05 for each analysis