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Article History

Received: 21 January 2026

Accepted: 19 March 2026

First Online: 25 March 2026

Declarations

:

: Not applicable.

: All subjects will receive written and oral information about the aims of the study, possible hazards, and the mechanism of treatment allocation by their treating physiscian. They will be informed about the strict confidentiality of their patient data, but that their medical records may be reviewed for trial purposes by authorized individuals other than their treating physician. It will be emphasized that the participation is voluntary and that the patient is allowed to decline further participation whenever he wants. If the patient wishes to withdraw from the study, he will be offered the standard treatment at the clinic. A signed, informed consent must be obtained from the patient before study entry. In the cases were the patient declines to participate in the study the conventional treatment according to local practice should be offered. Applicable details from this protocol and all accompanying material provided to the patient, such as written patient information used to obtain informed consent, has been submitted by the investigator to the Swedish Ethical Review Authority. Approval from the authority has been granted 2021–06-22 (ref.nr. 2021–02766), amended 2023–03-07 (ref.nr. 2023–01224-02), 2023–07-19 (ref.nr. 2023–04372-02), 2024–06-05 (ref.nr. 2024–02744-02) and 2025–03-18 (ref.nr. 2025–01461-02) and from the Regional Committee for Medical and Health Research Ethics, Mid-Norway (ref. no. 752599). Any significant changes to the protocol will be submitted for renewed ethical review.

: Maira Zia is employed by Antaros Medical and declares no competing interests. All other authors declare no competing interests.The authors declare no competing intereests..