Funding for this research was provided by:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (4402643-6)
Received: 19 May 2020
Accepted: 19 July 2020
First Online: 31 July 2020
Ethics approval and consent to participate
: This study has been evaluated and approved by the Research Ethical Board of the <i>Universidade Federal de São Paulo</i> (UNIFESP) in Brazil (2.263.749). Informed consent for each participant will be obtained during the onsite eligibility evaluation by the evaluator. The participants will have time to consider and ask the evaluator questions before giving consent. No safety monitoring committees are needed for this trial because the interventions had a low level of risk to patient safety. However, participant safety will be monitored by the steering committee (composed of the trial’s investigators) and monitored independently by the local ethics committees. The PI is responsible for sending partial reports (every 6 months), and the final report, when the study is completed, to the Research Ethical Board of the UNIFESP.
: Not applicable.
: The authors declare that they have no competing interests.