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Tirzepatide for weight reduction in Chinese adults with obesity: the SURMOUNT-CN randomized clinical trial [published correction appears in JAMA

21 CFR 314.94: Content and format of ANDA This regulation defines the required content for an ANDA, including stability data derived from exhibit batches

J Ren Nutr 2022;32:641-649

therefore, drugs that induce CYP3A may decrease nirmatrelvir and ritonavir plasma concentrations and reduce PAXLOVID therapeutic effect [see Contraindications (4) and Drug Interactions (7.3) Table 2]

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For the co-primary endpoint of percentage reduction in LFC of 30% from baseline to week 48, a placebo effect of 30% and a survodutide effect of 60% were assumed, whereas participants with early treatment discontinuation were assumed to be nonresponders