2.3. Ethical Aspects
A signed informed consent form was obtained from each participant as recommended in the Declaration of Helsinki, modified in the Tokyo Congress, Japan. The research was approved by the Ethical, Biosecurity and Investigation Committees of the National Institute of Cardiology (registration number INCICh: PT 10-0-76) and Centro Medico ABC Campus Observatory number ABC-18-19, Trial Registration: ClinicalTrials.gov Identifier: NCT 03557229.