Randomization and masking
Assignment of the treatment with the investigational medicinal product in the different doses vs. placebo to each treatment number was performed in a centrally conducted, computer-generated 1:1:1 randomization procedure. Treatment kits were manufactured by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany, according to the randomization list (as sequentially numbered containers). Patients were assigned a treatment number in an ascending mode according to their chronological order of inclusion. Investigators and trial participants were masked to the treatment as investigational medicinal products were identical in appearance.