Received: 23 March 2020
Accepted: 8 October 2020
First Online: 15 October 2020
Ethics approval and consent to participate
: Trial 1: The Phase III Clinical Trial (EudraCT 2017-000142-22) was performed in 447 patients in Germany, Bulgaria and Moldova. A separate Pharmacokinetic Arm was included in the trial protocol, including 27 additional patients in Germany. Participation in the clinical trial required written informed consent from all patients enrolled. The Clinical Trial was approved by the appropriate Independent Ethical Committees (IECs) in all three countries. These are: Ethics Committee of the State Board of Physicians, Thuringia (Germany); Ethics Committee for Multicenter Trials, Ministry of Health (Bulgaria); National Committee for Ethical Expertise of Clinical Trial, Ministry of Health (Moldova). Trial 2: n.a.; Trial 3: n.a.
: Not applicable.
: Heiko Brunner and Rudolf A. Theodor are employees of HELM AG.