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Trough FEV 1 FF/VI 100/25mcg vs. PBO FF/VI 100/25mcg vs. FF 100mcg FF 100mcg vs. PBO. 0-24hr wmFEV 1 FF/VI 100/25mcg vs. PBO FF/VI 100/25mcg vs. FF 100mcg FF 100 vs. PBO. Co-primary. If p<0.05 for co-primary endpoints move to secondary 1. Rescue-free 24hr periods
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Trough FEV1 FF/VI 100/25mcg vs. PBO FF/VI 100/25mcg vs. FF 100mcg FF 100mcg vs. PBO 0-24hr wmFEV1 FF/VI 100/25mcg vs. PBO FF/VI 100/25mcg vs. FF 100mcg FF 100 vs. PBO Co-primary If p<0.05 for co-primary endpoints move to secondary 1. Rescue-free 24hr periods FF/VI 100/25mcg vs. PBO FF/VI 100/25mcg vs. FF 100mcg FF 100mcg vs. PBO If p<0.05 for secondary 1. move to secondary 2. Secondary 2. Symptom-free 24hr periods FF/VI 100/25mcg vs. PBO FF/VI 100/25mcg vs. FF 100mcg FF 100mcg vs. PBO If p<0.05 for secondary 2. move to secondary 3. 3. AQLQ+12 FF/VI 100/25mcg vs. PBO FF/VI 100/25mcg vs. FF 100mcg