Institutional Review Board Statement
The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional Review Board (or Ethics Committee) OF. Approved by the Ethics Committee of the Faculty of Medicine of the University of São Paulo (FMUSP) n° CAAE: 39202214.8.0000.0065 date 11.20.2017 (Registered in ClinicalTrials.gov, identifier: NCT03792646).