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Article History

Received: 28 August 2025

Accepted: 9 November 2025

First Online: 12 December 2025

Declarations

:

: The study protocol and subsequent amendments were approved by the local Health Research Ethics committee (reference number: H-19031685), the Danish Health Authorities, and registered at ClinicalTrials.gov (NCT04179552). The participants gave informed consent prior to participation and reconsent for participation in the extension. The study was conducted according to the principles of Good Clinical Practice.

: Not applicable.

: HB and MH have received travelling grants from Contura International A/S. HB has received consulting fees, honoraria, research or institutional support, educational grants, equipment, services or expenses from Abbott, Abbvie, Amgen, AstraZeneca, Aventis, Axellus, Bristol Myers Squibb, Cambridge Weight Plan, Contura, Dansk Droge, Eurovita, Ferrosan, GlaxoSmithKline, Hoechst, LEO, Eli Lilly, Lundbeck, MSD, Mundipharma, Norpharma, NOVO, NutriCare, Nycomed, Pfizer, Pharmacia, Pierre-Fabre, Proctor&Gamble, Rhone-Poulenc, Roche, Roussel, Schering-Plough, Searle, Serono, UCB, Wyeth. PGC has received consulting or speaker fees from AbbVie, Eli Lilly, Eupraxia, Formation Bio, Genascence, Grunenthal, Levicept, Medipost, Novartis, Pacira, Stryker and Takeda. MH has received consulting fees from the Thuasne Group and Leo Pharma and is associate editor of Osteoarthritis and Cartilage. JB and AH have reported no conflicts.