Document is current

Article History

Received: 21 January 2025

Accepted: 7 July 2025

First Online: 26 August 2025

Declarations

:

: The clinical trial will be conducted in accordance with the protocol, the principles of the Declaration of Helsinki, in accordance with the Tripartite Harmonized Guide for Good Clinical Practice and following the current legal regulations (Royal Decree 1090/2015, December 4th).The study protocol has been evaluated and approved by the Ethics Committee (CEIm) of the Hospital de la Santa Creu i Sant Pau and authorized by the Spanish Medicines Agency (AEMPS).The informed consent will be requested from all the participants in the trial, respecting their willingness and autonomy in the decision. The participant information sheet will be provided beforehand, and any doubts they may have will be resolved before the trial initiation. Consent will be documented by the signature and date of the patient on the corresponding form, together with the signature and date of the person in charge of the trial explanation and request for consent. The patient or patient’s legal representative must be informed in a timely manner of any information that may have a relevant influence on the patient’s willingness to participate in the study. Two copies of the informed consent will be signed. One copy will be kept by the participant and the other by the investigator, who will keep it in the investigator’s file along with the rest of the study documents. Likewise, it will be documented in the clinical records of the patient that he/she agrees to participate in the clinical study and who signs the consent form.

: Consent will be obtained directly from the participants, as explained above.

: The authors declare that they have no competing interests.