Patients and methods
ICH
This double-blinded, randomized and placebo-controlled phase IV study was conducted from January 2012 to March 2015 in 40 sites in Germany. This study was conducted in compliance with the ICH Guideline E6 (R1) on Good Clinical Practice and registered under EudraCT no. 2010-020882-25. Several ethic committees were involved, including a leading committee in Berlin and local ethic committees in regions with participating centres.