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BACKGROUND: Mirabegron, a βべーた₃-adrenoceptor agonist, has been developed for the treatment of overactive bladder (OAB). OBJECTIVE: To assess the efficacy and tolerability of mirabegron versus placebo. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomised double-blind, parallel-group placebo- and tolterodine-controlled phase 3 trial conducted in 27 countries in Europe and Australia in patients ≥18 yr of age with symptoms of OAB for ≥3 mo. INTERVENTION: After a 2-wk single-blind placebo run-in period, patients were randomised to receive placebo, mirabegron 50mg, mirabegron 100mg, or tolterodine extended release 4mg orally once daily for 12 wk. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients completed a micturition diary and quality-of-life (QoL) assessments. Co–primary efficacy end points were change from baseline to final visit in the mean number of …