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Article History

Received: 12 July 2019

Accepted: 3 September 2019

First Online: 18 September 2019

Ethics approval and consent to participate

: The investigation conforms to the principles outlined in the Declaration of Helsinki. The study protocol was approved by the Ethics Committee of the University Würzburg on 15/05/2018 (Nr. 59/18 sc). Eligible patients will receive written information about all relevant aspects of the study and that their participation in the study is voluntary and they have the right to refuse or to withdraw their consent at any time without reprisals. Patients providewritten informed consent. The study has been registered with the German Clinical Trials Register DRKS00016034). This paper contains the original study protocol. Any substantial modifications to the study protocol will be submitted to the Ethics Committee of the University Würzburg for approval prior to implementation. These amendments will be documented in detail in the German Clinical Trials Register and will be described transparently in trial reports.

: Not applicable.

: The authors declare that they have no competing interests.