Institutional Review Board Statement
This protocol was previously approved by the National Ethics Committee in Research with Human Beings of Santa Casa de Misericordia (process number 178/2012) and registered at ClinicalTrials.gov NCT02409160. The study was conducted in accordance with the Regulatory Norms for Research Involving Human Subjects of the National Health Council of the Ministry of Health, RESOLUTION No. 466, on 12 December 2012.