Ethics approval and consent to participate
The trial was conducted according to the International Conference on Harmonization Good Clinical Practice Guideline, the Declaration of Helsinki, and local regulatory requirements. An independent ethics committee/institutional review board at each site approved the study protocol. Participants and study partners provided written informed consent. The study was approved by Cuban Health Ministry (000010/2016) and Cuban Regulatory Agency (CECMED) (June 15, 2017). All data were kept confidential. Patient data were pseudo-anonymized, using a subject identification number which carried no information about the patient but could be referenced on a database with patient information if required.