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Article History

Received: 24 January 2019

Accepted: 17 December 2019

First Online: 27 December 2019

Ethics approval and consent to participate

: This trial was approved by the Institutional Review Board/Institutional Ethical Committee (IRB/IEC) of the Medical Faculty of the University of Cologne and the ongoing trial is under continued review by the IRB/IEC (Trial number: 18–129). The trial was also approved by the local IRB/IEC prior to initiation of the trial at the local trial sites Tuebingen (Medical Faculty of the University of Tuebingen, reference number: 311/2018BO1), Bonn (Medical Faculty of the University of Bonn, reference number: 125/18), Mannheim (Medical Faculty Mannheim of the University of Heidelberg, reference number: 2018-555 N-MA), Leipzig (Medical Faculty of the University of Leipzig, reference number: 172/18Ik) and Freiburg (Faculty of Medicine of the University of Freiburg, reference number: 166/18). For the trial site Berlin (Charité, University Medicine) the process was led and coordinated by the ethical committee of the Medical Faculty of the University of Cologne (reference number: 18–129). Written informed consent is provided by all participants prior to any study procedure.

: Not applicable.

: The authors declare that they have no competing interests.