Received: 15 May 2018
Accepted: 24 April 2020
First Online: 6 May 2020
Ethics approval and consent to participate
: All participants provided formal consent prior to the participation in the study. The present study was approved by the Ethics and Research Committee of São Paulo State University (UNESP) (numbers 11547013.2.0000.5402 and 6727715.1.0000.5402/2015), and registered on ClinicalTrials.gov (NCT02804308) and on Brazilian registration clinical trial (RBR-85vmkz).
: All the authors reviewed and approved the final manuscript.
: The authors declare that they have no conflict of interests.