The extra 25 people recruited was to add a sub study on the effects of HA-I on the body (can't remember the medical term, just look at the Feb/March announcement). Even though this will be added to the statistics, I believe they should not be included in the primary endpoint count as the purpose was for a different reason and that the 25 people are using HA-I.
questions re phase 3 trial, page-8
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