I think we need to settle down a little, it is pretty hard language you are using. You cannot make assumptions without all the information particularly when they are not in control of many of the elements required to run through the process of enrolment through to the actual operation. It sounds to me from your comments that you have never run a project of any significance or any project for that matter, these are peoples lives they are dealing with not organising a kids party at Maccas.
Cleveland Clinic has enrolled patients in EFS, page-20
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