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Efficacy of Duloxetine in the Treatment of Diverse Women With Stress Urinary Incontinence*

METHODS: The 10-week study of open-label duloxetine 40 mg twice daily included 3,983 women with stress urinary incontinence or stress-predominant mixed incontinence. Efficacy was measured by the median percent change from baseline to endpoint of weekly incontinence episode frequency. The primary objective assessed the relative treatment response in a prespecified group of women (N 2,960) with similar baseline incontinence and comorbidity characteristics as the participants enrolled in placebo-controlled trials, where the efficacy has been demonstrated. The efficacy in diverse women compared with white women was evaluated using a predefined noninferiority analysis.