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Authors
Mathiesen, Anne Sophie https://orcid.org/0000-0002-1354-1012
Zoffmann, Vibeke
Lindschou, Jane
Jakobsen, Janus Christian
Gluud, Christian
Olsen, Markus Harboe
Rasmussen, Bodil
Marqvorsen, Emilie Haarslev Schröder
Rothmann, Mette Juel
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Funding
Funding for this research was provided by:
Copenhagen University
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Article History
Received: 6 February 2024
Accepted: 28 October 2024
First Online: 11 November 2024
Ethics approval and consent to participate
: The trial has been approved by the Danish Data Protection Agency (P-2020–864). The Ethics Committee of the Capital Region of Denmark reviewed the trial protocol on two occasions but exempted the trial protocol from full review (H-20003638) dated 16 January and 18 August 2020. All participants were given written and oral information and consideration time prior to signing informed consent.
: Not applicable.
: The second author, Vibeke Zoffmann, is the founder of the GSD methods and thus inflicts a potential vested bias. As outlined in this statistical analysis plan, none of the investigators will be involved in the analyses, which will be executed by external statisticians. The remaining authors declare that they have no competing interests.
