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Article History

Received: 30 September 2024

Accepted: 5 November 2024

First Online: 5 December 2024

Declarations

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: Information about the study is presented to all potential participants both verbally and in written form. At the information meeting and in the informed consent form it is made clear that the intervention is voluntary and safe, and that participants can stop their participation in the project at any time and withdraw their consent without consequences for the treatment they receive. If the participants wish to withdraw from the experiment during the intervention, there are three options: 1) They withdraw from the intervention but not from the study, therefore they will participate in the data collection at the follow-ups. 2) They withdraw from both the intervention and the study, but data from the baseline measures can be used in the research project. 3) They withdraw from both the intervention and the study, and their data will be deleted.The study will be conducted in agreement with the Declaration of Helsinki []. The Regional Ethical Committee for the Capital Region has decided that the study is not required to seek approval under their legislation (2313949), which covers human participation in medical trials. We will adhere to all other ethical standards guiding good practice in research. The study has been registered with the Danish Data Protection Agency (p-2023–14655), and we will comply with data security and GDPR regulations. The study has been registered at clinicaltrials.gov (NCT06251908), registration date 02.02.2024. If any modifications are made to the data collection or data analyses, these protocol amendments will be reported to the Danish Data Protection Agency and to clinicaltrials.gov. The intervention is not expected to have any serious side-effects. This is supported by the pilot study and similar studies [].

: N/a.

: The authors declare no competing interests.