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Authors
Harvey, Lisa A. https://orcid.org/0000-0002-4365-0236
Glinsky, Joanne V.
Chu, Jackie https://orcid.org/0000-0001-5810-2788
Herbert, Robert D.
Liu, Hueiming https://orcid.org/0000-0001-9077-8673
Jan, Stephen
Billot, Laurent https://orcid.org/0000-0002-4975-9793
Scivoletto, Giorgio https://orcid.org/0000-0001-5766-6952
Spooren, Annemie I.
Seelen, Henk A.
Ben, Marsha
Tranter, Keira
Chen, Lydia W.
Rainey, Donna
Rimmer, Christine
Jorgensen, Vivien https://orcid.org/0000-0001-9437-7009
Di Natal, Fernanda
Denis, Sophie
Gollan, Emilie J.
Tamburella, Federica https://orcid.org/0000-0001-9920-1010
Agostinello, Jacqui
van Laake-Geelen, Charlotte M.
Bell, Chris
Lincoln, Claire
Stolwijk, Janneke M. https://orcid.org/0000-0001-6793-691X
van der Lede, Jessica
Paddison, Sue
Oostra, Kristine
Cameron, Ian D.
Weber, Gerard
Sherrington, Catherine
Nunn, Andrew K.
Synnott, Emma-Leigh
McCaughey, Euan https://orcid.org/0000-0001-6596-110X
Kaur, Jasbeer
Shetty, Sachin
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Funding
Funding for this research was provided by:
NSW Ministry of Health, Australia; and Wings for Life Foundation, Austria.
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Article History
Received: 16 November 2022
Revised: 20 June 2023
Accepted: 23 June 2023
First Online: 6 July 2023
Competing interests
: The authors declare no competing interests.
: Ethical approval has been obtained from the ethics committees representing the Northern Sydney Local Health District (for the Australia sites, 2020/ETH02540), Fondazione Santa Lucia IRCCS (for the Italian site; Prot. CE/PROG.928), Medical Ethics Committee of Maxima Medical Centre, Veldhoven (for the Adelante site and De Hoogstraat Rehabilitation Site in The Netherlands: CCMO code: NL78377.015.21), Central Committee on Medical Research Involving Human Subjects, Norway (for the Norwegian site, 278129), the NHS Research Health Authority (for the UK sites: 21/YH/0306), and Ethische Commissie Onderzoek UZ/KU Leuven (for the Belgium sites: S65931). Ethical approval will be sought for any future protocol modifications. Any changes to the protocol will be updated on the registry. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval, the NHMRC National Statement on Ethical Conduct in Human Research (2007), and the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95). The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conference.
