Funding for this research was provided by:
Innovation Fund of the German Federal Joint Committee (01VSF16023)
Received: 4 July 2019
Accepted: 25 July 2019
First Online: 1 November 2019
Ethics approval and consent to participate
: The study is carried out following the Helsinki Declaration of the World Medical Association and according to the principles of good clinical and good scientific practice. Study participation is voluntary and can be withdrawn at any time. Written and audio-recorded informed consent will be obtained prior to participation, if applicable. Patients will be fully informed about aims, procedures, data collection and the use of collected data in this study. Rejecting participation has no negative consequences for patients. No foreseeable risk results from participating. No compassionate use is carried out. No invasive intervention is conducted. This study is registered at ExternalRef removed (NCT03795948). Principles of data protection will be kept. Approval of the local ethics committee (Ethik-Kommission der Ärztekammer Hamburg) has been obtained (PV54565, 14.03.2017). The results of this study will be disseminated via peer-reviewed journals. Deviations from protocol, i.e. inclusion, recruitment, procedure, and statistical data analysis will be discussed. The plot of our description is oriented on the SPIRIT guidance for protocols of clinical trials [CitationRef removed].
: Not applicable.
: LR, LL, MF, HA, HJB, LK, and MH have no conflict of interest. CG reports personal fees from Amgen, Bayer Vital, Bristol-Myers Squibb, Boehringer Ingelheim, Sanofi Aventis, Abbott, and Prediction Biosciences outside the submitted work. GT reports receiving consulting fees from Acandis, grant support, and lecture fees from Bayer, lecture fees from Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, and Daiichi Sankyo, and consulting fees and lecture fees from Stryker outside the submitted work.