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MISTIE III Enrollment Review for July 2016


As of end-July 2016, we are at 356 enrollments (of 500). Over the trailing 12-month period (TTM), we have enrolled 178 subjects, an average of 14.8 per month. The number of actively-recruiting sites each month (activated less closures and temporary holds) is relatively stable at around 75 sites, and it seems likely that the current average enrollment rate will continue. Extrapolating, we are therefore on track to complete enrollment in around 10 months (May-2017), about 2 months ahead of plan. In our enrollment data, there is notable month-to-month variability, a possible seasonality effect, and a limited performance history with the later-starting ex-US sites that suggest a 2-month collar is reasonable (e.g., enrollment should complete in Mar-Jul period).



Enrollment at the Australia-Asia sites, managed by the George Institute (GI or TGI), is averaging around 0.75 randomizations per month (over the TTM period). At this rate, they will contribute around 20 to 24 subjects by enrollment completion.

Enrollment in the MTI substudy (across 23 of the M3 sites) is proceeding smoothly at approximately 4.3 subjects per month.  At completion of enrollment in the overall trial, there should be approximately 90 subjects in this substudy (red line in the graph below).



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