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Article History

Received: 27 July 2022

Accepted: 8 August 2022

First Online: 19 August 2022

Declarations

:

: Ethical committee procedures are being followed in all sites. Inclusion of participants at a site can start after ethical approval by the local review board. Any modifications to the protocol which may impact on the conduct of the study or potential benefit of the participant including changes of study objectives, study design, study population, sample sizes, study procedures, or significant administrative aspects are submitted as an amendment to the local ethical review board. The names of the review boards and the approval references are: Valencia, Spain: Ethics committee for research with medicines of the university clinical hospital of Valencia, ref. no. 2021/316; Heerlen, The Netherlands: Medical Ethical Committee (MEC) – Erasmus University Medical Center Rotterdam, ref. no. MEC-2022–0150; Leeds, United Kingdom: Ethics committee University of Leeds—AREA (Faculties of Business, Environment and Social Sciences), ref. no. 21–070; Edirne, Turkey: Trakya University Edirne Clinical Studies Ethical Committee, ref. no. 07/01; Obuda, Hungary: Scientific and Research Ethics Committee of the Medical Research Council of Hungary, ref. no. 332/2022, and; Jelgava, Latvia: Central Medical Ethics committee of Latvia, ref. no. 01–29.1.2/2267. Informed consent is collected on paper by a research assistant. A subsample of the participants are invited for the qualitative part of the study. Those are provided with an additional information leaflet, and sign an additional consent form.Participants can stop their participation at any time during the study, without disclosing reasons for withdrawing.

: Not applicable.

: The authors declare that they have no competing interests.