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In Reply: Dr Armstrong and colleagues are concerned that we have compromised a phase 1 study design by incorporating a sample size calculation and by using historical data as a statistical comparator. Traditional phase 1 investigations, or first-in-human studies, are used to determine the dose and schedule of an investigational therapeutic while assessing for potential toxic effects.1
Youngster I, Hohmann EL. Fecal Microbiota Transplantation for Clostridium difficile Infection—Reply. JAMA. 2015;313(7):726. doi:10.1001/jama.2014.18619
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