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Message: Re: What would a successful BETonMACE Top-Line Data Announcement Look Like?
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Aug 10, 2019 10:09PM

Tada: I remember something to the same effect as you regarding the non-compliant patient. However, as far as I remember, Resverlogix did not say that if the patient been included in the placebo group, the results would have been statistically significant. I do not remember the actual percentage plaque. I think the lack of compliance was for the very last study visit (where no active component was found in plasma) - there might have been compliance earlier in the study.

Perhaps more importantly, I also remember clearly that that specific patient suffered from a myocardial infarction while having the final examination. Had the patient been counted as placebo, the 3-point mace score for the ASSURE study would have been nicer to look at... Anyway, the only valid way of looking at data is to use intent-to-treat, which would keep the non-compliant patient in the originally designated groups.

 

BR.

BKC

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