Ethics approval and consent to participate {24}
MAY
Ethical approval for this trial, which is in compliance with the Helsinki Declaration and in agreement with the SPIRIT statement, was obtained for the Ethics Committee of Principado de Asturias dated 26 August 2021 to corresponds to version 2.1 (19 August 2021). The protocol amendment version 3.0 was approved by the AEMPS on 27 May 2022.The subsequent informed consent form will be obtained from all the participants. According with the current legislation regarding to clinical trials (RD 1090/2015), the AEMPS will be notified of the start of the clinical trial. The obtained personal data and biological samples of all patients will be treated with confidentiality and security, in accordance with the regulations based on Regulation (EU) 2016/679 and Law 14/2007 on Biomedical Research.The clinical trial has been classified as a low intervention level clinical trial (ECBNI) and is, therefore, in accordance with the current legislation RD1090/2015, which specifies that low intervention level studies do not need to be covered by an insurance contract or financial guarantee, if they are covered by the individual or collective professional liability insurance or equivalent financial guarantee of the health site where the clinical trial is carried out. This is the responsibility of each site and not of the sponsor.