1110 patients screened
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52 discontinued: AE 1 Lack of efficacy 32 Protocol deviation 7 Lost to Follow-up 0 PowerPoint PPT Presentation


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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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52 discontinued ae 1 lack of efficacy 32 protocol deviation 7 lost to follow up 0

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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