Mooser, Blandine
Bergsma, Dominique
Liechti, Fabian D.
Baumgartner, Christine
Gentizon, Jenny
Méan, Marie
Wertli, Maria M.
Mancinetti, Marco
Schmidt-Leuenberger, Joachim
Aubert, Carole E. https://orcid.org/0000-0001-8325-8784
Funding for this research was provided by:
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (PZ00P3_201672)
Article History
Received: 23 May 2023
Accepted: 6 September 2023
First Online: 31 October 2023
Declarations
:
: This study is conducted in compliance with the Declaration of Helsinki [], the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice [, ] and the Swiss human research legislation (Swiss Federal Human Research Act 810.30 and Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices 810.305). Patient participation is voluntary and written informant consent is obtained by all participants or their proxy in case of cognitive impairment. The protocol was approved by the local ethical committees (“Ethikkommission für die Forschung am Menschen – Universität Bern”, "Ethikkommission Nordwest- und Zentralschweiz (EKNZ)", "Commission cantonale d'éthique de la recherche sur l'être humain du canton de Vaud (CER-VD") and the study registered before pilot study initiation, on the Clinical Trials Registry platform of the National Institute of Health (NIH) – clinicaltrials.gov (NCT05639231, first release on December 19, 2022) – and on the Swiss National Clinical Trial Portal (SNCTP000005259, first release on November 28, 2022).
: Study participants are informed that the results of the study will be published in peer-reviewed journals and provide written informed consent on that.
: The authors declare no competing interests.