Funding for this research was provided by:
Received: 16 July 2020
Accepted: 26 July 2020
First Online: 5 August 2020
Ethics approval and consent to participate
: Before the trial was initiated, this trial received ethical approval from the Ethics Committee described below for the trial protocol, written informed consent form and consent form updates.CEIC Hospital Universitario La Paz. Área Sanitaria 5 de la CCAA de MadridPaseo de la Castellana, 261, 28046 Madrid.Ref: 47/027899.9/20, June 11<sup>th</sup> 2020.Informed consent will be obtained before conducting any study-specific procedures.Eligible subjects will be informed before the beginning of the study about the objectives and procedures, as well as the potential risks derived from their study participation.The process of obtaining informed consent will be documented in the subject source documents.
: Not applicable.
: GE and DA-C are Scientific Advisors of Pharmamel LTD, the Sponsor of the clinical trial.