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Article History

Received: 7 April 2026

Accepted: 20 August 2026

First Online: 26 August 2026

Declarations

Ethics approval and consent to participate: This study was conducted in accordance with international ethics guidelines, including the most recent version of the Declaration of Helsinki. All recruitment procedures, site investigators, and researchers participating in this study complied with Good Clinical Practice (GCP) guidelines, including the International Conference on Harmonization Guidelines. In the US, the study protocol was reviewed and approved by the centralized WCG™ Institutional Review Board (IRB) and the local Mass General Brigham IRB under partial Health Insurance Portability and Accountability (HIPAA) waiver, approval number 20244971. For the Netherlands, documents were not reviewed by IRB as the study was not considered under the Dutch Medical Research Involving Human Subjects Act (Wet Medisch-wetenschappelijk Onderzoek met mensen; WMO) and WMO granted exemption, exception number 2024–17856. Applicable federal, state, local laws, rules, and regulatory requirements in the USA and the Netherlands were adhered to throughout the study. All participants provided written informed consent.

Consent for publication: Written informed consent for publication of data was obtained from all study participants.

Competing interest: JS, CAH, HR, GR and JL are Khondrion employees. JR, JB and TA are employees of COS, and have no other disclosures. MCHJ and AK report no competing interests relevant to the manuscript.