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Article History

Received: 1 February 2024

Accepted: 18 November 2024

First Online: 30 November 2024

Declarations

:

: The study protocols have been reviewed and approved in the six cities. The clinical trial of Barcelona received the approval of Research Ethics Committee (REC) at UVic-UCC with registration number 2014/2022 on 28 June 2022 and Primary Health Care Research Institute of Catalonia with the registration number 22/170-P on 02/08/2022. Moreover, the consortium obtained the approval of the Helsinki University Hospital Ethics Committee (No. HUS/119/2022). They also received approval from Social Services and Health Care of the City of Helsinki on 13 June 2022. The protocol in Prague was approved by the Ethics Committee of the Faculty of Humanities, Charles University, on June 28, 2022. The protocol in Cuenca, Ecuador, was approved by the Committee of Bioethics (Comité de Bioética en Investigación del Área de la Salud (COBIAS)) on June 28, 2022 (2022-001EO-I). The protocol in Melbourne, Australia, was approved by the Human Research Ethics Committee (HREC) Research and Innovation Office NH&MRC Code: EC00237 on October 10, 2022. The protocol in Marseille, France, was approved by the Comité d’éthique de l’université d’Aix-Marseille on January 10, 2023. The three trial protocols have been published at . Protocol numbers are as follows: Barcelona Trial: NCT05488496, Prague Trial: NCT05522140, and Helsinki Trial: NCT05507684. Informed consent was obtained from all study participants before enrollment in the study. Human subjects’ data generated throughout this project was anonymized, and safeguards were in place to ensure protection of human subjects’ data.

: Not applicable.

: The authors declare that they have no competing interests.