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Hosai

01/03/25 1:28 PM

#478645 RE: Doc328 #478638

Yes I agree that 'status' likely refers more to a category rather than continuous measure.
However considering the eligibility criteria stipulates only people above 20 MMSE - ("A Mini-Mental state examination (MMSE) score of 20 to 28 at the screening and randomization visits") - it would seem surprising if the only pre-specified MMSE baseline co variant adjustment was whether above or below 20 (when clearly they were expecting almost all to be between 20 and 28). It would seem more likely the co-variate adjustment means selected categories between 20 and 28 such as 21-24 / 25-28.
The MMSE table given of above or below 20 may be simply to show the number of patients in the aimed for eligibility criteria.
We cannot know for sure how it was done at this point, similarly all the other co-variates (such as country or other medications) are not specified in regards to their criteria.