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09/04/17 3:01 AM

#195620 RE: BonelessCat #195619

Thx LBK

Wouldnt those 10 addtl Subjects come in blinded again with a certain ratio of Verum and Placebo?

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sox040713

09/05/17 12:51 AM

#195661 RE: BonelessCat #195619

LBK, I'm hoping for reason 3. Enrollment rate was ~10%, or ~20 patients, per month. This means it took about 2 weeks to recruit 10 patients. If IPIX's goal was 189 patients, there could be one or two patients overlapped on the last day of enrollment. That's why I don't think the additional 10 patients were the result of overlapping.

Adding 10 patients to the 400 mg arm would mean they want to confirm something they are seeing, most likely efficacy. It would also change the randomization ratio to 2:2:1 (placebo:300mg:400mg). Of course the reason for the additional 10 patients could be as simple as replacing some dropouts. We shall see.

3) however, most likely but needs confirmation, add reliability to the 400mg arm if it showed greater efficacy than 300mg.