Moreno, Ainhoa Fernández
Lavín-Alconero, Lucía
de Ugarriza, Paula López
Blanco, Laura Solán
Hernández, Sara Cáceres
Burgués, Juan Miguel Bergua
de Miguel, María Izquierdo
Huerta, Ana Julia González
Zarzuela, Marta Polo
Boluda, Blanca
Humala, Karem
Calabuig, Maria Luisa
Amigo, Maria Luz
Casas, Marián Cuesta
del Mar García-Saiz, María
Verdugo, Ana Fernández
Domínguez, Javier Fernández
Bernal, Teresa http://orcid.org/0000-0002-2338-513X
Funding for this research was provided by:
Instituto de Salud Carlos III (FIS PI21/01590)
Article History
Received: 31 July 2023
Accepted: 4 October 2023
First Online: 27 October 2023
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 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.
: No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.
: The authors declare that they have no competing interests.