Estebanez, Elena Bustamante
Alconero, Lucía Lavín
Fernández, Beatriz Josa
Marguello, Monica Gozalo
Caro, Juan Carlos López
Vallejo, Jonathan Diez
Sampedro, Marta Fernandez
Cacho, Pedro Muñoz
Espiga, Carlos Richard
Saiz, María Mar García
Funding for this research was provided by:
PRIMARY CARE RESEARCH PROJECTS SUPPORT PROGRAM (PRIM-VAL) 2020
Article History
Received: 10 March 2021
Accepted: 13 August 2021
First Online: 6 September 2021
Declarations
:
: 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 Cantabria dated 5 May 2020 (record 11/2020) to correspond to version 2.2 (29 April 2020); the following amendment is dated 9 October 2020 (record 24.2020) to correspond to version 3.0 (22 September 2020).The subsequent informed consent form will be obtained from all the participants. According to the current legislation regarding 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). Therefore, in accordance with current legislation RD1090/2015 which specifies that low intervention level studies do not need to be covered by an insurance contract or financial guarantee, 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 the Marques de Valdecilla University Hospital and not of the sponsor.
: Not applicable
: The authors declare that they have no competing interests.