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While the applicant submitted results from both a phase 2 trial of REBYOTA TM [90] and the PUNCH CD3 phase 3 trial [91] to demonstrate the superiority of REBYOTA TM over placebo, we question whether other treatment options indicated to prevent rCDI, such as ZINPLAVA TM , would be a more appropriate comparator

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Birth Defects Res Part C Embryo Today Rev

doi: 10.1038/s41572020-01562 171 TianTWangZZhangJ

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