Ethics approval and consent to participate
All protocols in this study were followed conducted in accordance with the Helsinki Declaration (1989 revision) and Ethical approval for this study was obtained from the Iran University of Medical Sciences Ethics committee (IR.IUMS.FMD.REC 1396.9413468004; research.iums.ac.ir). The study was registered at the Iranian Registry of Clinical Trials (IRCT201709239472N16;). All participants were informed of the study's purposes and signed written informed consent.