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Article History

Received: 25 December 2018

Accepted: 24 May 2019

First Online: 20 June 2019

Ethics approval and consent to participate

: Central ethical approval has been confirmed from the “Ethikkommission Nordwest- und Zentralschweiz” (ref. approval no. 2018-00976), and local ethical approval has been obtained for all study sites. Thus, local ethical approval has been obtained from the “Ethikkommission Nordwest- und Zentralschweiz” for the clinics located in Basel, Riehen, and Solothurn, and from the “Ethikkommission Bern” for the clinic located in Münchenbuchsee. The intervention study was registered in the WHO trial register (trial number ISRCTN10469580). All participants will be informed about the general goals of the study. Informed written consent is required before study entry. The study will be carried out in accordance with the ethical principles laid down in the Declaration of Helsinki (1964). Important protocol modifications will be communicated to participants and trial registries.

: After completion of the data assessment, all personal data of the patients will be encoded (each patient will receive a project ID number), so that it will no longer be possible to identify the patients. No publication of case reports is planned where the manuscript could contain individual person’s data.

: The authors declare that they have no competing interests.