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Researchers conducted a multicenter, randomized, placebo-controlled, double-blind phase 3 clinical trial in Japan from October 17, 2017 to September 30, 2019

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Lack of FDA Approval : BPC-157 is not an FDA-approved medication, and the FDA compounding materials list certain bulk drug substances as presenting significant safety risks

The theoretical rationale for combination is sound, but no controlled human study has evaluated the pair

Blood chemistry parameters remained within normal ranges throughout extended treatment periods

Each batch of AOD-9604 is produced through standardized synthetic peptide manufacturing processes designed for consistency and reproducibility