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Article History

Received: 28 October 2025

Accepted: 15 June 2026

First Online: 23 June 2026

Declarations

:

: This trial is conducted in accordance with the CIP, the ethical principles of the Declaration of Helsinki, the principles of SS-EN ISO 14155:2020, and all applicable national and international regulations. These measures ensure both participant safety and data quality. The trial did not commence until the required regulatory and ethical reviews were completed with non-negative outcomes, in compliance with the MDR and national legislation. Any additional requirements imposed by the Ethics Committee or regulatory authorities are implemented accordingly. The protocol (version 2.0), worksheets, PISs, informed consent forms, and all other trial materials were approved by the Swedish Medical Products Agency on November 6, 2024 (Dnr: 5.1-2024-92319) and the Swedish Ethical Review Authority on December 18, 2024 (Dnr: 2024-07362-01). The first substantial amendment to the protocol (version 3.0/Amendment 1), replacing version 2.0, was approved by the Swedish Ethical Review Authority on June 25, 2025 (Dnr: 2025-04238-02) and by the Swedish Medical Products Agency on July 1, 2025 (Dnr: 5.1-2024-92319 [5.1.1-2025-050512]). Individual written informed consent to participate is obtained from all eligible patients prior to enrollment. All clinical investigation team members received training in Good Clinical Practice (GCP) and trial procedures before initiating data collection. The trial is registered at ClinicalTrials.gov (NCT06781801; date registered: 16 January 2025).

: Not applicable.

: The trial is registered at ClinicalTrials.gov, and summary-level results will be submitted for publication in peer-reviewed scientific journals. The first results are expected to be available in 2027. Findings will also be shared at national and international conferences, through meetings with regional health authorities, and via various media channels. Trial participants are informed that they may obtain trial results through the site’s PI once available. The trial also includes collaboration with the Schizophrenia Association in Gothenburg to facilitate communication of results to broader audiences. All abstracts and publications will adhere to the authorship criteria recommended by the International Committee of Medical Journal Editors (ICMJE). The full trial CIP is available at ClinicalTrials.gov (NCT06781801).

: The authors declare no competing interests.