Ethics Approval
Study approval was obtained for the cluster randomized clinical pilot from the Ethics Committee for Clinical Research of the HCB (HCB/2018/0805), and the trial was registered at ClinicalTrials.gov (NCT04056663) on August 14, 2019. Patients read, understood, and filled out the informed consent form, which was signed before enrollment in the study. The Ethics Committee for Medical Research of HCB approved the premarket pilot study (HCB/2016/0883). Informed consent forms were understood, accepted, and signed by all the included subjects.