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Article History

Received: 31 July 2024

Accepted: 18 July 2025

First Online: 30 August 2025

Declarations

:

: The study received approval from the Research Ethics Committee of the University of Salamanca (Registration number: 0001180) (Date: 02/07/2024) and obtained prior written informed consent from the study subjects. The study was conducted in accordance with the Helsinki Declaration []. Participants were informed of the project's objectives and the risks and benefits of the interventions that would be carried out. Participants will receive full information about the study, and we guarantee that their data will be treated with the utmost confidentiality both during and after the study. Therefore, data and information will not be shared with any third parties. The researchers involved in the study will adhere strictly to professional confidentiality guidelines. Participants'confidentiality will be guaranteed at all times in accordance with the laws on the protection of personal data and biomedical research, as presented in the provisions of Organic Law 3/2018 of December 5 on the Protection of Personal Data and the Guarantee of Digital Rights, Regulation (EU) 2016/679 of the European Parliament and Council of 27 April 2016 on data protection (GDPR), and under the conditions established by Law 14/2007 on biomedical research.Any significant modifications to the protocol, such as changes in the evaluation tools, selection criteria, or interventions, will be promptly communicated to the Ethics Committee.As this is a randomized clinical trial, it adheres to the CONSORT guidelines and has been registered with ClinicalTrials.gov (ID: NCT06326151).

: Not applicable.

: The authors declare no competing interests.