Composition of the coordinating center and trial steering committee
The coordinating center is located at the promotor’s site. It is composed of the principal investigator, the methodologist and statistician, the promotor data manager, and the promotor study coordinator. They will meet annually and in addition whenever there are queries from participating centers. In each participating center, the site investigator and study coordinator will meet annually and in case of queries. The promotor’s clinical research committee will adjucate the end of the trial.