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OBJECTIVES Active-comparator, non-inferiority study designs are used in uncomplicated urinary tract infection (uUTI) to establish the efficacy of a new antibacterial, given the availability of effective antibiotics. We estimate the treatment effect of a planned antimicrobial comparator (nitrofurantoin), from historical trial data, to properly design an upcoming non-inferiority study in uUTI. METHODS A systematic literature review and meta-analysis were conducted in compliance with the Preferred Reporting Items for Systematic Reviews and M