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Authors
Nyholm, Anne Marie https://orcid.org/0000-0001-9497-6853
Esbensen, Bente Appel
Westergaard, Caroline Louise
Kjellberg, Jakob
Juhl, Carsten Bogh
Olsen, Bo Sanderhoff
Odgaard, Anders
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Funding
Funding for this research was provided by:
Region Hovedstaden
Novo Nordisk Fonden (NNF210C0067043)
Copenhagen University
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Article History
Received: 12 October 2024
Accepted: 21 November 2025
First Online: 12 December 2025
Declarations
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: This trial has been approved by our regional Ethics committee (Center for Sundhed De Videnskabsetiske Komiteer, Region Hovedstaden, Denmark) with Journal nr.: H-23039139, with a date of registration 2nd of October 2023. The participant will give written informed consent prior to inclusion in the trial. Should any important protocol modifications be necessary, the regional Ethics committee will be contacted for approval prior to making the changes. If any modifications will have an impact on the included patients, they will be informed of the changes via a secure personal email system, with an invitation to contact the steering committee with any further questions.
: Anders Odgaard is a founder of Procordo Software and remains a minority stockholder. Procordo is the manager of the trial database. AO will participate in the construction and management of the trial database. All economic negotiations between Procordo and the project will be without involvement or intervention from AO.Bente Appel Esbensen, Anne Marie Nyholm, Carsten Bogh Juhl, Bo Sanderhoff Olsen, Caroline Louise Westergaard, and Jakob Kjellberg declare that they have no competing interests in relation to this trial.
