Received: 17 August 2019
Accepted: 18 January 2020
First Online: 19 February 2020
Ethics approval and consent to participate
: The sponsor, the investigator and Swiss Ethics Board have approved the trial’s protocol version 2, dated 30 October 2018. This trial will be conducted according to the ethics protocol and standards of the current version of the World Medical Association Declaration of Helsinki, the ICH GCP Guidelines and the ISO 14155, which will be applied to the local legal requirements. Informed consent will be obtained from all study participants as a requirement to participate in the study.
: All participants have given consent for publication of the anonymous data by giving written and spoken “informed consent” in context of the study inclusion.
: The authors declare that they have no competing interests.