Fernández, Ana I.
Bermejo, Javier
Yotti, Raquel
Martínez-Gonzalez, Miguel Ángel
Mira, Alex
Gophna, Uri
Karlsson, Roger
Al-Daccak, Reem
Martín-Demiguel, Irene
Gutiérrez-Ibanes, Enrique
Charron, Dominique
Fernández-Avilés, Francisco
Fernández, Ana I.
Bermejo, Javier
Yotti, Raquel
Gutierrez-Ibanes, Enrique
Gabaldón-Badiola, Álvaro
Martín-Demiguel, Irene
Sanz, Ricardo
Martínez-Legazpi, Pablo
Elízaga, Jaime
Fernández-Avilés, Francisco
Jurado, Elena
Martínez-Gonzalez, Miguel Ángel
Razquin, Cristina
Vázquez-Ruiz, Zenaida
Mira, Alex
López, Aránzazu
Ferrer, Maria D.
Gophna, Uri
Reshef, Leah
Karlsson, Roger
Moore, Edward
Karlsson, Göran
Winqvist, Anna
Al-Daccak, Reem
Charron, Dominique
,
Funding for this research was provided by:
Instituto de Salud Carlos III (INTIMIC-138)
Agence Nationale de la Recherche (INTIMIC-138)
Ministry of Science Research and Technology (INTIMIC-138)
Svenska Forskningsrådet Formas (INTIMIC-138)
H2020 European Research Council (INTIMIC-138)
Article History
Received: 10 March 2021
Accepted: 22 October 2021
First Online: 12 November 2021
Declarations
:
: The protocol has been approved by the Ethics Committee of the Hospital General Universitario Gregorio Marañón, Madrid, Spain (CEIC 209/18). The protocol is in accordance with the principles of the Declaration of Helsinki. Any changes to the protocol would be notified to the sponsor and the Ethics Committee first; then, the PI will notify to the partners and the PI will update the protocol in the clinical trial registry. The present trial is registered in ExternalRef removed, NCT03842319, on 13 May 2019. All participants provide written informed consent before randomization after the objectives and methodology of the trial have been explained to them in detail by the investigators. Participants have the right to withdraw from the trial at any time without giving a reason and will not be disadvantaged in any way for doing so. On the consent form, participants are asked if they agree to the use of their data should they choose to withdraw from the trial. Participants are also asked for permission for the research team to share relevant data with people from other institutions taking part in the research or from regulatory authorities, where relevant. This trial involves collecting biological specimens for storage. Investigators are responsible for ensuring that all participant data remains confidential. The participants’ personal information complies with the provisions of EU Regulation 2016/679 (European Parliament and of the Council of April 27, 2016, Data Protection).There is no anticipated harm and compensation for trial participation.
: Not applicable
: The authors declare that they have no competing interests.