Ethics approval and consent to participate
MAY
The Ethics Committee at Rostock University Medical Centre approved the DEBATE trial on May 25th, 2011 under the reference A 2011-59. Ethics Committees at the Medical Faculty of the Heinrich-Heine-University Dusseldorf (July 19th, 2011, reference 3676) and at the University of Witten/Herdecke (July 12th, 2011, reference 78/2011) confirmed scientific adequacy. Written informed consent was obtained from all participants. All methods were conducted in accordance with relevant ethical guidelines and regulations.