CONSORT 2010 checklist of information to include when reporting a randomised trial*.
(PDF)Click here for additional data file.(DOCX)Click here for additional data file.(PDF)Click here for additional data file.(PDF)Click here for additional data file.The authors would like to thank analyze & realize GmbH, Prof. Ralf Uebelhack and participating investigators and sites for their invaluable contribution to the conduct of the trial.