Lorenzo-Luaces, Patricia
Sanchez, Lizet http://orcid.org/0000-0001-7747-1052
Saavedra, Danay
Crombet, Tania
Van der Elst, Wim
Alonso, Ariel
Molenberghs, Geert
Lage, Agustin
Funding for this research was provided by:
Flemish Interuniversity Council
Article History
Received: 13 November 2019
Accepted: 10 August 2020
First Online: 17 August 2020
Ethics approval and consent to participate
: The trial protocol, informed consent, investigator brochure, and case report forms were approved by the ethic boards from each participating institution, including the main investigation site: Hermanos Ameijeiras Hospital and by the Cuban Regulatory Agency (CECMED). Informed consent was obtained from each subject before entering in the study. The trial was conducted in accordance with the principles of the declaration of Helsinki and Good Clinical Practice guidelines. It was registered at the Cuban Registry of Clinical Trials, a WHO-validated public registry ExternalRef removed, trial number RPCEC00000161).
: This manuscript does not contain any details, images, or videos that might leed to identification of an individual patient.
: The authors declare that there are no conflicts of interest.