4.11. Ethical Aspects
A signed informed consent form was obtained from each participant in accordance with the Declaration of Helsinki, as amended at the Congress in Tokyo, Japan. This research was approved by the Ethics, Biosafety and Research Committees of the National Institute of Cardiology (INCICh registry number: PT 10-0-76) and the ABC Campus Observatory Medical Center, approval number ABC-18-19; Registry of Trial: Clinical-Trials.gov Identifier: NCT 03557229.