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"Further, while we acknowledge the corrective and preventive actions that your site has taken or plans to take, your written response is inadequate because it does not provide sufficient details about how you, as a clinical investigator, will ensure adequate oversight of the study procedures (for example, adherence to eligibility requirements)

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Although the gut microbiota in females is larger and more diverse than that in males, the greater incidence of URIs in females (Groeneveld et al., 2020) with concomitant microbiota depletion may explain the female gender disparity in these syndromes