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Article History

Received: 24 November 2017

Accepted: 28 June 2018

First Online: 18 July 2018

Ethics approval and consent to participate

: The final study protocol was approved by the ethics committee of the Medical Faculty of the University of Leipzig (Kaethe-Kollwitz-Str. 82, 04109 Leipzig; Germany; Trial registration number: DRKS00011036 on DRKS at 16th January 2017) in accordance with the declaration of Helsinki, the “Medical Association’s Professional Code of Conduct” and the principles of ICH-GCP guidelines (issued in June 1996, ISO14155 from 2012). In addition, the German Medical Devices Act (MPG, §§ 20-23a) was followed. Furthermore, local legal and regulatory authorities as well as the medical secrecy and the Federal Data Protection Act will be followed. All local ethics committees of the participating centers consented to the master ethics committee approval. Prior to enrollment, each patient will be given detailed information about the aims, scope and possible consequences of the trial by a physician. No diagnostic or interventional procedures required for the clinical trial will be performed without obtaining written consent from the patient.

: Not applicable.

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