Ziegler, Andreas http://orcid.org/0000-0002-8386-5397
Mann, Miriam
Brandewiede, Bernard
Dittrich, Hermann
Hintz, Sissy
Krockenberger, Katja
Öner, Alper
de Sousa, Marcos Oliviera
Schmidt, Christian
Funding for this research was provided by:
Gemeinsamer Bundesausschuss (01NVF16003)
Article History
Received: 30 October 2019
Accepted: 6 January 2020
First Online: 3 February 2020
Ethics approval and consent to participate
: Ethics approval of the initial study protocol, patient information and informed consent form was obtained from the Ethics Committee of the Medical Faculty of the University of Rostock on 18 July 2017, and its registration number is A 2017–0117. The SAP and all its amendments was approved by the Ethics Committee on 20 August 2019. Written informed consent for trial participation will be obtained from all patients prior to randomization.
: Not applicable.
: Sissy Hintz and Drs. Miriam Mann, and Marcos Oliviera de Sousa are employees of Universitätsmedizin Rostock Versorgungsstrukturen GmbH, a subsidiary of Universitätsmedizin Rostock. Prof. Schmidt is board member of the Universitätsmedizin Rostock. Prof. Ziegler was CEO of StatSol and is CEO of Cardio-CARE AG. Dr. Katja Krockenberger is an employee of AMEDON GmbH. Bernard Brandewiede is CEO of AMEDON GmbH. All other authors declare no conflict of interest.