Funding for this research was provided by:
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (PCEGP1_186913)
Article History
Received: 11 April 2024
Accepted: 10 June 2024
First Online: 8 August 2024
Declarations
:
: Ethical and professional guidelines will be followed at all times, in line with Good Clinical Practice guidelines. The trial has been approved by the Competent Ethics Committee (Kantonale Ethikkommission Bern, approved 08–22-2022) and the Competent Authority (Swissmedic, approved 08–22-2022). The trial amendment (i.e., if more than 1 month has passed since the last follow-up assessment of the EMERGE study, the follow-up assessment will be repeated as the baseline assessment of the EMPATIA study to re-evaluate the in- and exclusion criteria for the EMPATIA study. No further changes are made to the recruitment method.) was approved by both committees (approved, 10–26-2023). All participants (or their legal guardians when participant is younger than 14 years old) will provide oral and written informed consent before participating in the trial.
: For the study model informed consent forms, see Additional file 4. As we have not included any details, images, or videos relating to an individual person, no consent for publication of the protocol had to be obtained.
: The authors declare that they have no competing interests.