1. 379 failed screeninga 120 failed run inb
1110 patients screened
Excluded (n=499)
379 failed screeninga 120 failed run inb
610 randomizedc
609
(ITT population)
203 received placebo OD
205 received FF 100mcg OD
201 received FF/VI 100/25mcg OD
52 discontinued: AE 1
Lack of efficacy 32
Protocol deviation 7
Lost to Follow-up 0
Investigator discretion 6 Withdrew consent 6
20 discontinued: AE 0
Lack of efficacy 6
Protocol deviation 0
Lost to Follow-up 1
Investigator discretion 7 Withdrew consent 6
22 discontinued: AE 2
Lack of efficacy 7
Protocol deviation 2
Lost to Follow-up 2
Investigator discretion 6 Withdrew consent 3
151 completed the study
185 completed the study
179 completed the study