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( ( ( ( ( ( ( ( After review of the information provided by the applicant, we have the following concerns regarding whether TERLIVAZ meets the substantial clinical improvement criterion

In a clinical trial of semaglutide injection for weight loss (Wegovy) in patients with T2DM and a BMI of 27 kg/m2 or more, hypoglycemia (defined as a plasma glucose less than 54 mg/dL) was reported in 6.2% of semaglutide-treated patients versus 2.5% of placebo-treated patients

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