Trial design cam be adjusted/reviewed at the interim's, this has not happened so far with ARDS P3, only real change that I can see was inclusion of AU Hospital in the trial recruitment. So it is all going as planned without any tweaks required so far.DSMB would have advised of the need to make changes at interims part of the set protocols.
Ann: Novartis and Mesoblast Remestemcel-L Collaboration, page-673
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