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FDA staff recommended against inclusion, noting a single 46-person BPC-157 trial and no human studies of KPV, and said rulemaking of roughly 8 to 12 months would be needed before compounding is unambiguously lawful (PharmExec, July 24, 2026)

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interestingly, supporting its protective role, a recent phase 4 clinical trial demonstrated that a combination of rosuvastatin and ezetimibe significantly improved homeostasis model assessment of β-cell function compared to rosuvastatin monotherapy [56,57]