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The selection of the animal species and models are a critical consideration, guided by similarities to the expected human biological response to the drug of interest
Statistical analysis Data were analyzed using one-way analysis of variance (ANOVA) followed by Tukeys post hoc test, performed with GraphPad Prism 9 software (9.5.1, Boston, USA)
The 10mg format improves operational efficiency for labs by minimizing vial changes while maintaining precise formulation standards
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associated taxa compared to placebo, which accelerates microbiome recovery from antibiotics, the applicant cited one unpublished study showing treatment with SER-109 led to a significant decrease in ARG abundance versus placebo, which was both rapid and sustained through week eight
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