Document is current

Article History

Received: 4 September 2018

Accepted: 3 May 2019

First Online: 17 May 2019

Ethics approval and consent to participate

: All procedures were approved by the Friedrich-Alexander-Universität Erlangen-Nürnberg Ethics Committee (Ref. 360_16 B). The study centre is located in Erlangen and is the primary coordinating centre. Two further therapy centres are located in Weyarn and Berlin. The Ethics Approval covers all participating sites. Participation is voluntary and participants are free to leave the study at any time without suffering any disadvantages. Participants do not receive any financial inducement to participate. All of the participants are being informed about the study by one of the researchers at the study’s headquarters, either during the informational session or in a face-to-face meeting. A patient information sheet including all important information about participation (e.g. randomisation, data protection, data storage) is being handed out to every participant. The opportunity to ask questions is being granted at the informational sessions or by telephone and e-mail afterwards at any time. Written informed consent is being obtained from all participants prior to their inclusion in the study.

: Not applicable.

: The authors declare that they have no competing interests.

: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.