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FDA data shows that a single dose of tirzepatide cuts peak blood level of the hormones in birth control pills by 5566%
Secondary Outcome: Secondary Outcomes: Changes in waist circumference, body fat, body lean mass, and metabolic risk factors including levels of plasma glucose, insulin sensitivity, serum lipids, and blood pressure Statistical Analysis Full details previously published 2 and can also be found in the STEP group statistical analysis plan at NEJM.org Statistical analysis approach sought strong control for type I error All endpoints addressing intervention efficacy were analyzed using intention-to-treat approach All endpoints addressing intervention safety were analyzed using per-protocol approach Efficacy endpoints analyzed using 2 estimands Treatment Policy Estimand: intention to treat analysis
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