Ethical approval
The study protocol was approved by the Spanish Drug Agency (AEMPS for its initials in Spanish), with a protocol version 1 approval date of 15/03/2021, and was registered in the Spanish Clinical Trials registry (REEC) under the number 2020-003776-41 and the protocol version 2 extension was approved on 31/01/2022. The study was registered in ClinicalTrials.gov under the number NCT05594355 on 26/10/2022. The ethical committee of the Universitat Internacional de Catalunya reviewed and approved the protocol. The patient and a close relative or legal representative read the patient information sheet, agreed to participate in the trial, and then signed the informed consent form. The study was conducted in compliance with a clinical protocol, regulatory requirements, good clinical practice (GCP), and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association.