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Article History

Received: 13 January 2025

Accepted: 7 April 2025

First Online: 26 April 2025

Declarations

:

: The study protocol received approval from the ethical committee of the Capital Region of Denmark (ID: H-20022320) and the Danish Medicines Agency (ID: 202002033425). In addition, a legal data handling agreement was secured from the Capital Region of Denmark (ID: 2020-866). In compliance with Danish legislation, informed consent was initially provided by an independent primary trial guardian before a patient's inclusion and was later confirmed by a secondary trial guardian.

: Consent, including consent for publication, was also obtained from a surrogate, and from the patient themselves if they were deemed cognitively capable after regaining consciousness, as soon as possible following their admission. The trial was monitored for safety and overall conduct by a Data and Safety Monitoring Board and adherence to national and international guidelines was overseen by the Good Clinical Practice unit of Copenhagen. The trial was conducted under the Declaration of Helsinki.

: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.