Jimenez-Vazquez, David https://orcid.org/0000-0002-2837-339X
Garcia-Lopez, Luis-Joaquin https://orcid.org/0000-0003-0446-6740
Zafra-Palomino, Laura https://orcid.org/0009-0006-1918-7479
Funding for this research was provided by:
Universidad de Jaén
Article History
Received: 4 June 2025
Accepted: 4 September 2025
First Online: 30 October 2025
Declarations
:
: The study was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT: ) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials). The trial was pre-registered in the ClinicalTrials.gov registry under the identifier NCT06185049. Ethical approval was granted by the Institutional Review Board (IRB), and the research was authorized by the Bioethics Committee of the University of Jaén (ID: GEN-3461-aab8-41a3-85c2-ca28-5102-cdda-8d53). The study design was aligned with internationally recognized standards for clinical research (ICH-E6, E8, and E9), with additional guidance drawn from sources such as the European Medicines Agency (EMA), and it complied with current data protection legislation (Regulation (EU) 2016/679).
: Informed consent was obtained from all participants involved in the study, and written consent was additionally secured from the parents or legal guardians of underage participants.
: The authors have no conflicts of interest to declare that are relevant to the content of this article.