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First Online: 28 March 2020

Compliance with Ethical Standards

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: This study and the Open Access fee were funded by the Berlin Cures Holding AG. The authors have no other relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject or materials discussed in the manuscript apart from those which are disclosed.

: Niels-Peter Becker, Annekathrin Haberland, Katrin Wenzel, Peter Göttel, Gerd Wallukat, Hanna Davideit, Sarah Schulze-Rothe, Anne-Sophie Hönicke, Ingolf Schimke, Sabine Bartel, Johannes Müller, Susanne Becker are employed at Berlin Cures GmbH. Annekathrin Haberland, Peter Göttel, Gerd Wallukat, Ingolf Schimke, Johannes Müller are shareholders of Berlin Cures Holding AG, the parent company of the Berliner branch Berlin Cures GmbH. All other authors have nothing to declare.

: The study was conducted in accordance with the principles set forth in the Declaration of Helsinki as amended in 1996, the Guidelines of the International Council for Harmonisation (ICH) on Good Clinical Practice (GCP) (CPMP/ICH/135/95), as well as the requirements of the European Union Data Protection Directive 95/46/EC and other applicable regulatory requirements. The study was approved by the Berlin ethics commision “Landesamt für Gesundheit und Soziales Berlin, Ethikkommission des Landes Berlin”.

: Before each subject was enrolled in this clinical study, written informed consent was obtained according to the regulatory and legal requirements of the country which hosted the study.