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52 discontinued: AE 1 Lack of efficacy 32 Protocol deviation 7 Lost to Follow-up 0

1110 patients screened. Excluded (n=499) 379 failed screening a 120 failed run in b. 610 randomized c. 609 (ITT population). 203 received placebo OD . 205 received FF 100mcg OD. 201 received FF/VI 100/25mcg OD. 22 discontinued: AE 2 Lack of efficacy 7 Protocol deviation 2

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52 discontinued: AE 1 Lack of efficacy 32 Protocol deviation 7 Lost to Follow-up 0

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  1. 1110 patients screened Excluded (n=499) 379 failed screeninga120 failed run inb 610 randomizedc 609 (ITT population) 203 received placebo OD 205received FF 100mcg OD 201 received FF/VI 100/25mcg OD 22 discontinued:AE 2 Lack of efficacy 7 Protocol deviation 2 Lost to Follow-up 2 Investigator discretion 6Withdrew consent 3 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 6 151 completed the study 185 completed the study 179 completed the study

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