Document is current

Article History

Received: 9 August 2017

Accepted: 17 September 2018

First Online: 24 September 2018

Ethics approval and consent to participate

: The trial is planned and is conducted according to the principles as stated in the Declaration of Helsinki, applicable local regulations, including German drug law (AMG) and the rules for good clinical practice (ICH-GCP, GCP-V). The trial was initiated after approval by the responsible Ethics Committee of the Medical Faculty of the University of Heidelberg (“Federführende Ethikkommission”), all other ethics committees responsible for the study centers (“Beteiligte Ethikkommissionen”, the full list with names of all ethics committees can be found in Additional file), and the competent authority (The Federal Institute for Drugs and Medical Devices, BfArM). All study centers were initiated after approval obtained by the local ethics committees responsible for the participating study centers. The trial was registered in a clinical trial register before the first patient was recruited.For each participant in this clinical trial written informed consent is obtained.

: Not applicable.

: The authors declare that they have no competing interests.

: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.