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Re: VuBru post# 104511

Monday, 04/17/2017 2:03:30 PM

Monday, April 17, 2017 2:03:30 PM

Post# of 429217
"If those analyses suggest the number of patients with at least 1 adjudicated, primary event (and appropriately accounting for patients with potential primary events for which the adjudication process is then incomplete) is consistent with projections, then the study could continue toward the protocol-specified target enrollment of 7990 patients. However, if the number of such events appears less than, and inconsistent with projections, the Sponsor will consider (under blinded conditions) re-calculating the number of patients needed to achieve the target number of events within the desired timeline or extend the follow-up period. If the projected increase in number of patients is ?25% of the original 7990 target population, the Sponsor may, with documented approval of both the REDUCE-IT Steering Committee (SC) and the Data Monitoring Committee (DMC), extend enrollment to the revised target number without need for an additional protocol amendment."

What about the fact that total enrollment was 8175 and not 7990, does it mean that events were slightly underperforming or they could have been added to make up for dropouts?
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