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Article History

Received: 17 August 2020

Accepted: 23 October 2020

First Online: 4 January 2021

Ethics approval and consent to participate

: The study has been approved by the Ethical Committee of the Medical University of Vienna and by the Austrian Agency for Safety and Health Care (BASG). Moreover, the clinical trial has been officially registered on the European Clinical Trial Database. The investigator ensures that this study is conducted in full conformance with the principles of the “Declaration of Helsinki” (as amended at the 64th WMA General Assembly, Fortaleza, Brazil, 2013) and with the laws and regulations of the country in which the clinical research is conducted. All studies will follow the ICH GCP Guidelines and the regulatory requirements. This study follows the EU Directive embedded in the Austrian drug act. During their participation in the clinical trial, the patients will be insured as defined by legal requirements. Written, informed consent to participate will be obtained from all participants.

: All the authors declare that they have no competing interests.

: All the participants gave their consent for publication of trial’s relevant information in a pseudo-anonymized form.