Funding for this research was provided by:
Conselho Nacional de Desenvolvimento Científico e Tecnológico (429849/2016-8)
National Institute of Science and Technology for Health Technology Assessment (17/2551-0000515-5)
Hospital de Clínicas de Porto Alegre (170044)
Received: 20 August 2018
Accepted: 14 May 2019
First Online: 29 May 2019
Ethics approval and consent to participate
: The study procedures were approved by the Ethics Committee/IRB from the Hospital de Clínicas de Porto Alegre (CAAE: 62427616.0.1001.5327) and Federal University of Pelotas (CAAE: 62427616.0.2001.5313), and adhered to Good Clinical Practices. The informed consent document includes the objectives of the study, a description of the testing procedures, explanation about interventions and its randomized allocation nature, the potential risks and benefits involved in the study, the costs to the participants, information on anonymized data sharing, and liabilities of the particular participating center. A copy of the consent form is given to the participant (or legal guardian), and this fact is documented in the subject’s record. The investigator charged of providing study clarifications and seeking the participant’s ethical consent must allow the subject sufficient time to decide whether or not to participate in the trial. Once a subject decides to participate, a signed and personally dated informed consent is obtained from the subject before any trial-related procedure.Any modifications to the protocol which may impact relevant changes to study procedures (e.g., changes in eligibility criteria, assessments, information on risk/benefit) or to administrative routine require a formal amendment to the protocol. Although such protocol changes may be applicable to only one center (e.g., inclusion of an assessment procedure for a given center), any amendment should have the approval of both centers coordinators and be approved by the Ethics Committee/IRB prior to implementation. This manuscript is accompanied by a description of existing amendments (Additional file InternalRef removed).
: Not applicable.
: DU receives research productivity grant and support from the CNPq foundation. CEB receives post-doctoral fellowship funding support from the IATS foundation. LH, LPS, LOP and ADN receive doctoral funding support from the CAPES foundation. BDS, CLA and CAP receive research productivity grant and support from the CNPq foundation. All other authors have no competing interests to disclose.
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