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Russian clinical trials have contributed valuable data, but methodological differences, including smaller sample sizes, different statistical approaches, and less rigorous blinding procedures compared to FDA standards, mean that Western regulatory agencies generally do not accept this data for drug approval

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In reality, many of these are still being evaluated, and their regulatory status is actively evolving

They boost natural production rather than replacing it, maintaining feedback mechanisms and potentially carrying lower risk profiles

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[DOI] [PMC free article] [PubMed] [Google Scholar] 13.Jesaitis LA, Goodenough DA