Ethical approval and consent to participate
All procedures performed in the present study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declarations and its later amendments or comparable ethical standards.The clinical study protocol was approved by the Ethics Committee of the Hospital Clinic San Carlos in Madrid (C.P.-C.I. 14/532-P) and followed the ethical principles founded in the Declaration of Helsinki. The protocol was registered in ClinicalTrials.gov (identifier NCT05051839). Informed consent was obtained from all individual participants included in the present study. They were informed verbally and in writing of the advantages and disadvantages of participating in the study.