Study design, ethics approval, and registration
This study was a randomized controlled trial with two groups (the AO group and the control group). It was approved by the Ethics Committee of the University of Aveiro (21-CED/2020). All participants signed an informed consent before entering the study. Before the enrollment of the first participant, the study was registered at clinialtrials.gov (NCT05078489) on 14/10/2021.