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Article History

Received: 12 September 2024

Accepted: 10 January 2025

First Online: 8 April 2025

Change Date: 18 April 2025

Change Type: Update

Change Details: The original publication was amended to delete Supplementary file 2.

Declarations

:

: All participants provided informed consent before being enrolled in the study. This study was conducted in compliance with Good Clinical Practice, including International Conference on Harmonization Guidelines and was consistent with the most recent version of the Declaration of Helsinki. Additionally, all applicable local laws and regulatory requirements were adhered to. Before recruiting participants, all study documents were submitted to and approved by an independent institutional review board at each site. All personal data were managed to ensure compliance with applicable national and/or local laws, and regulations on personal data protection.

: Not applicable.

: LG, SCH, DN, FL, PB, VK and JFH are employees of F. Hoffmann-La Roche Ltd. KB was an employee of Fortrea Development Limited, Budapest, Hungary, providing services to F. Hoffmann-La Roche Ltd., when this study was conducted. AR has been a paid consultant and has received research support from F. Hoffmann-La Roche Ltd. He has also consulted, participated on advisory boards or received recent research support from Autifony, BioMarin, Brainsway, CRE Medical, CURE, Encoded, LouLou Foundation, Marino’s, Neurocrine, Neuroelectrics, Ovid, SSADH Foundation, and Takeda. He is co-founder and has equity in Neuromotion, PrevEp, and Galibra.