Defino, Helton L. A.
Costa, Herton R. T.
Nunes, Altacílio A.
Nogueira Barbosa, Marcello
Romero, Valéria http://orcid.org/0000-0002-3278-5223
Article History
Received: 28 December 2018
Accepted: 14 August 2019
First Online: 31 August 2019
Ethics approval and consent to participate
: The present study protocol was analyzed and approved by the Research Ethics Committee on February 20, 2017, with the process of the Clinical Hospital of Ribeirão Preto, São Paulo, Brazil, number 14625/2016.The present study was registered in ExternalRef removed and receipt of the results system (PRS). The approval number: 1.933.631. ExternalRef removed and the identifier code: NCT03316703 in may, 2017. The study was approved by the Institutional Review Committee (IRB) of all participating centers that agreed with the proposed study protocol (enrollment study), study initiation June 1, 2017. Informed consensus will be obtained prior to randomization and patients are free to refuse participation. Patients will receive no financial rewards for participating in the study and are free to withdraw from the study at any time without interruption of treatment and medical care.
: Not applicable in the section.
: The authors declare that they have no competing interests.