Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01KG09069)
Received: 5 July 2018
Accepted: 4 January 2019
First Online: 14 January 2019
Ethics approval and consent to participate
: The trial was approved in July 2009 by the ethics committee at the Landesärztekammer Rheinland-Pfalz (code: 837.211.09 (6717)) and the German Federal Institute for Drugs and Medical Devices (BfArM) approved the trial protocol. All study participants provided written informed consent at enrollment into the protocol treatment. The study was conducted in accordance with the Helsinki Declaration and is compliant with the CONSORT guidelines.
: Not applicable
: AT has received consultancy fees from Janssen and Novartis. All other authors declare that they have no competing interests.
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