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If satisfied, it grants a marketing authorisation (formerly known as a product licence)

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Sample Size Calculation The hypothesized superiority of semaglutide to liraglutide for the primary and confirmatory secondary end points was assessed using a predefined hierarchical gatekeeping approach (eTable 1 in Supplement 3), 10 with a statistically superior result (2-sided at the 5% significance level) required for each end point before the next could be tested
