Ethics approval and consent to participate
ICH
The study protocol received Institutional Review Board (Bellvitge University Hospital Ethics Committee) approval on April 8Informed consent was obtained from all subjects and/or their legal guardian(s). All methods were carried out in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines (ICH E6 R2). Patient confidentiality was guaranteed following the current Spanish legislation (LOPD 3/2018). This manuscript complies with the CONSORT 2010 statement.No human tissue samples were collected, used, or stored in this clinical trial.