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Heavy Reliance on Animal Models Most available evidence originates from rodent studies

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With respect to the claim that SER-109 reduces the abundance of antimicrobial resistance genes (ARGs) and associated taxa compared to placebo, which accelerates microbiome recovery from antibiotics, the applicant cited one unpublished study showing treatment with SER-109 led to a significant decrease in ARG abundance versus placebo, which was both rapid and sustained through week eight