Funding for this research was provided by:
P. Olander Medica Development AB (83433)
Lund University
Article History
Received: 1 September 2025
Accepted: 25 February 2026
First Online: 23 March 2026
Declarations
:
: The authors declare that they have no competing interests.
: The study was conducted following the principles of the Helsinki Declaration of 1975 and according to Good Clinical Practice (GCP). The study was approved by The Swedish Ethical Review Authority (EPM) (Dnr 2021-04061) and the Swedish Medical Council (CIV-SE-21-06-036906). The study was monitored by Clinical Studies Sweden and registered at (NCT05177692) (2021/12/14). An application was approved by the Scanian Healthcare Agency responsible for individual patient extraction (Samråd KVB, dossier no. 355-21). The enrollment of participants in the study was solely based on exclusion and inclusion criteria. The participant’s autonomy was highly valued, and when patients were providing consent, either by themselves or via next-of-kin, it was greatly emphasized that participation was voluntary. It was also emphasized that consent for participation in the study could be withdrawn without any consequences.
: NCT05177692; ClinicalTrials.gov (registered 14 December 2021) .