Ethics approval and consent to participate
The trial was approved by the ethics committee of the Iran University of Medical Sciences institutional review board (IR.IUMS.REC.1399.101) and carried out based on the Declaration of Helsinki and subsequent revisions. Written informed consent was obtained from all participants. Patients were reassured that their participation was voluntary and that they had the right to return to their usual treatment at any point in the study. The trial was registered at the Iranian Registry of Clinical Trials on 14/07/2020 (