Funding for this research was provided by:
Fundação de Amparo à Pesquisa do Estado de São Paulo (2016/17093-0)
Conselho Nacional de Desenvolvimento Científico e Tecnológico (311443/2014-1)
Received: 12 June 2019
Accepted: 24 July 2019
First Online: 14 August 2019
Ethics approval and consent to participate
: This protocol is approved by the Hospital Research Ethics Committee of the University of Sao Paulo (66375617.1.0000.0068). The study methodology was documented in a protocol and registered in Clinical Trials.gov PRS (Protocol registration and Results System): NCT-03705702 on 4 October 2018 prior to starting recruitment. All participants are given verbal and written information about the study and have to provide signed consent to participate in the research. The information collected about participants is individually identifiable by members of the research team only. Each participant will be allocated a unique numeric code (ID Number) such that all stored electronic data (e.g., databases, data files) will not contain identifiable data until the completion of the study. All confidential information is stored in locked filing cabinets, and only deidentified data will be presented or published.
: Not applicable
: The authors declare that they have no competing interests.