2.2. Ethical Considerations
ICH
The study was conducted in agreement with the general principles adopted by the international community regarding biomedical research in human subjects, with current state regulations according to the requirements of the Cuban national regulatory agency, as well as in the Guide to Good Clinical Practices of the International Harmonization Conference (ICH E6). Besides, it was approved by the Cuban Minister of Public Health, the Institutional Ethics Committees of each hospital, and CECMED. The informed written consent was obtained from the patients before their inclusion in the investigation.