Design
A pragmatic parallel-group, single-blinded, randomized pilot clinical
trial was conducted (UTN U1111-1250-9090; Brazilian Registry of Clinical
Trials RBR-3Z98RP) according to the recommendations of CONSORT, 2010
[27]. The study protocol was approved by the Research Ethics
Committee of the Santa Casa de São Paulo (permit CAAE
50268715.1.0000.5479) and was devised in compliance with the principles
of the Declaration of Helsinki. All participants signed the consent
form.