Alshami, Ali M. https://orcid.org/0000-0003-3263-8896
Bamhair, Duaa A.
Article History
Received: 16 March 2021
Accepted: 6 October 2021
First Online: 18 October 2021
Declarations
:
: This study was conducted in accordance with the Declaration of Helsinki and followed the guidelines of Consolidated Standards of Reporting Trials (CONSORT). Ethical approvals were obtained from the Institutional Review Board at the University of Dammam (IRB-PGS-2016-03-142, date: October 2, 2016) and Ministry of Health (A00395, date: December 18, 2016) before initiation. This trial was registered at the ClinicalTrials.gov (NCT 03328351; registration date: November 1, 2017). The purpose and potential risks of this study were fully explained to the participants. All participants provided written informed consent before participating in this study.
: Written informed consent for publication of individual details will be obtained from the trial participants. The consent forms are in the possession of the authors and are available for review by the Editor-in-Chief if required.
: The authors declare that they have no competing interests.