Bruhn, Maja http://orcid.org/0000-0002-7575-9199
Laugesen, Henriette
Kromann-Larsen, Matilde
Trevino, Cathrine Selnes
Eplov, Lene
Hjorthøj, Carsten
Carlsson, Jessica
Article History
Received: 5 September 2022
Accepted: 20 September 2022
First Online: 8 October 2022
Declarations
:
: The trial is conducted in accordance with the Helsinki II Declaration. Participation in the study is voluntary, requires written, informed consent, and is not a precondition for treatment. Participants can withdraw consent at any time. Randomisation is considered ethical, as current evidence does not favour one treatment over the other. No serious disadvantages or adverse events are expected in any of the groups of the trial. If adverse events occur, e.g. admission to hospital due to the intervention, they are registered by the investigator and assessed by the sponsor.The study is approved by the Danish Data Protection Agency (P-2019-327). All data collected for this project will be protected according to the General Data Protection Regulation (EU) 2016/679 (GDPR), Act on Processing of Personal Data as well as the Danish Health Act.The protocol was submitted to the Regional Ethics Committee for The Capital Region of Denmark for review (journal no. H-19067136). The Committee waived the need for approval due to the trial focusing on coordination of existing treatment rather than novel treatment modalities and for not being a biomedical trial. For further details or information, please contact: ExternalRef removed.The RCT is registered in the ClinicalTrials.gov register (NCT04244864). Important trial modifications are registered here.
: Not applicable.
: The authors declare that they have no competing interests.