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The European Medicines Agencys (EMA) Pharmacovigilance Risk Assessment Committee concluded that no product label update was warranted, based on data from clinical trials, real-world safety monitoring, and electronic health records [45]

Institutional Review Board Statement The animal study protocol was approved by the Institutional Animal Care and Use Committee (IACUC) of Qinghai University (protocol code PJ202501-55 and date of approval 12 March 2025)

The role of gut microbiota in the gut-brain axis: current challenges and perspectives

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