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Article History

Received: 15 July 2019

Accepted: 25 May 2020

First Online: 18 June 2020

Ethics approval and consent to participate

: This pilot trial followed the conditions of the Declaration of Helsinki [] and the ethical principles of beneficence, respect for persons, and justice as described in the Belmont Report []. All participants received essential information in oral and written forms and needed to provide written consent to participate. Participation was voluntary and could have been stopped anytime and without stating any reason. Furthermore, patient-related data were pseudonymized by using IDs and stored in a locked cabinet and password-protected database. Study personnel with partial access to data signed a non-disclosure agreement.Approval for this pilot trial was obtained from the Ethics Committee at the University of Freiburg (registration number: 407/17). The study was registered after ethical approval at the German Clinical Trials Register (Main ID: DRKS00012808) [], a primary study register approved by the World Health Organization.

: Not applicable

: All authors declare no competing interests.