Document is current

Article History

Received: 31 May 2022

Accepted: 8 October 2022

First Online: 21 October 2022

Declarations

:

: The study is conducted in accordance with the guidelines proposed in the World Medical Association Declaration of Helsinki and has been approved by national/regional Ethics Committees where the Clinical Trials of the project will be performed.Spanish clinical site: Approved by Comité de Ética de laInvestigación con Medicamentos (from the Hospital Universitario yPolitécnico La Fe).Portuguese clinical site: Approved by the Comissao de Éticapara a Sáude (from Santa Casa da Misericórdia da Amadora).Greek clinical site: Approved by the Bioethics and Ethics of theSchool of Medicine (from Aristotle University of Thessaloniki).UK clinical sites: Approved by the South Central -Oxford B Research Ethics Committee (from the NHS Health Research Authority).Written informed consent will be obtained from all participants at each site.

: Not applicable.

: The authors declare that they have no competing interests.