Kowark, Ana http://orcid.org/0000-0002-7433-8675
,
Rossaint, Rolf
Keszei, András P.
Bischoff, Petra
Czaplik, Michael
Drexler, Berthold
Kienbaum, Peter
Kretzschmar, Moritz
Rex, Christopher
Saller, Thomas
Schneider, Gerhard
Soehle, Martin
Coburn, Mark
Article History
Received: 9 March 2019
Accepted: 10 June 2019
First Online: 15 July 2019
Ethics approval and consent to participate
: The study was presented to the competent Ethics Committee of the Medical Faculty RWTH Aachen and all other involved local ethics committees of the participating centres prior to inclusion of any subject into the study. Approval was received on 8 August 2017 EK 104/17. In accordance with local legal requirements, study documents have also been submitted to the respective regulatory authority “Federal Institute for Drugs and Medical Devices (BfArM)” for separate approval. Approval with No. 4042066 was received on 17 July 2017.Any change in the study protocol and/or informed consent form will be presented to the competent ethics committee and the BfArM. The changes must be approved by the ethics committee and the BfArM before implementation (except for changes in logistics and administration or those necessary to eliminate immediate hazards).The notification of the clinical trial according to § 67 German Medical Act to the local supervising authority was performed before trial start. The authority will also be notified about any amendment and the study end.Written informed consent will be obtained from all patients prior to study participation. The patients will voluntarily confirm their willingness to participate in the study after receiving comprehensive written and verbal information from an investigator.
: Not applicable.
: AK is an associated editor of the <i>Trials</i> journal. The other authors declare that they have no competing interests.