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Article History

Received: 17 July 2025

Accepted: 15 December 2025

First Online: 18 February 2026

Declarations

:

: This study was reported in accordance with the CONSORT guidelines for randomized clinical trials [ ].

: The authors have declared that there are no competing interests.

: The datasets analysed during the current study are available from the corresponding authors on reasonable request. Data supporting the findings of this study are deposited in the University of Seville research data repository .

: This study was conducted in accordance with the principles of the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and applicable local regulatory requirements. The protocol was authorized by the Ethics Committee (CEIm Provincial de Sevilla) and the Spanish Regulatory Agency (AEMPS) on the 18 February 2019. Patient data were processed in compliance with European Union General Data Protection Regulation 2016/679 and Spanish Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights.

: Written informed consent was obtained from all participants prior to enrolment.

: Not applicable.

: Not applicable.

: Conceived the idea: Antonio Carrillo-Vico and Patricia Judith Lardone. Data collection: Silvia Jiménez-Jorge, María Ángeles Lobo-Acosta, Rocío López-Ruiz and Sara Eichau. Data Analysis: Silvia Jiménez-Jorge, Ana Isabel Álvarez-López, Eduardo Ponce-España. Pharmacovigilance: María Ángeles Lobo-Acosta, Clara M Rosso- Fernández. Clinical review of patients: María Ángeles Lobo-Acosta, Javier Ampuero, Manuel Romero-Gómez, Clara M Rosso- Fernández. Drafting of the manuscript: Ignacio Bejarano and Patricia Judith Lardone. Obtained funding: Patricia Judith Lardone, Clara María Rosso-Fernández, Juan Luis Ruiz-Peña and Antonio Carrillo-Vico. Administrative and technical support: María Ángeles Géniz, María Isabel García-Sánchez, Manuel Cameán, Vicente Merino-Bohorquez, Silvia Jiménez-Jorge, María Ángeles Lobo-Acosta and Guillermo Izquierdo. Critical revision of the manuscript: Patricia Judith Lardone, Antonio Carrillo-Vico, Ignacio Bejarano, Silvia Jiménez-Jorge, Rocío López- Ruiz, Sara Eichau, Juan Miguel Guerrero, Javier Ampuero, Manuel Romero-Gómez, María Ángeles Lobo-Acosta, Clara María Rosso-Fernández. Approval of the manuscript: all authors.