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Re: Doktornolittle post# 63947

Wednesday, 06/08/2016 2:49:50 AM

Wednesday, June 08, 2016 2:49:50 AM

Post# of 711654
There definitely were patients that remained in the trial after it's first attempt. This would have been the group that enrolled in the trial leading up to the hold. They are called the "vanguard" cohort. Those patients enrolled in the trial after the hold are called the "restart" cohort.

The following is per the April 2013 protocol.


Efficacy will also be reviewed at the two interim analyses plus one final
analysis. Overall cohort (i.e., all data from the beginning of the study,
followed by the “vanguard” cohort – i.e. those patients originally enrolled
prior to the hold and followed up to the current time, and a “restart cohort”,
i.e., those follow-up since the restart of the clinical trial (i.e., since August
2011). Although the primary view is towards all patients enrolled (i.e. overall
cohort), a consistency of effect across subsets would be the primary intent
of these additional cuts.



I believe those "vanguard" patients numbered approximately 22 or so from an original number of 33. The remaining 11 were enrolled into the information arm.

They will count towards the "overall cohort".
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