Received: 23 January 2019
Accepted: 26 June 2019
First Online: 7 August 2019
Ethics approval and consent to participate
: Ethics approval was obtained from the ethics committee of the Medizinische Hochschule Hannover (MHH) on September 27, 2017, and its registration number is 7614.Written informed consent for trial participation will be obtained from all patients prior to randomization.
: Not applicable.
: CvF, SK and PMV are employees of MHH, which receives a grant from Syntellix AG for conducting the trial. CP is an employee of Syntellix AG, and MHK is board member of Syntellix AG. KK is an employee of AMEDON GmbH, and BB is CEO of AMEDON GmbH. AMEDON GmbH provides trial services to Syntellix AG. AZ is a consultant to Syntellix AG.