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.