Kazemi, Sara
Zarei, Fatemeh https://orcid.org/0000-0003-1561-3646
Heidarnia, Alireza
Alhani, Fatemeh
Article History
Received: 17 January 2022
Accepted: 13 September 2022
First Online: 24 September 2022
Declarations
:
: The study protocol has been approved by the Medical Ethics Research Center of Tarbiat Modares University (reference: IR.MODARES.REC.1400.049). All participants will be provided with full information of their part in the study and assured that their information will be kept strictly confidential. All participants will be asked to complete a written informed consent form. This will provide a clear understanding that their participation is entirely voluntary, and they have a right to withdraw at any time during the study. The auditors will follow a monitoring plan to verify that the clinical trial is conducted and that data are generated, documented, and reported in compliance with the protocol and the applicable regulatory requirements. Due to the nature of the intervention, there is no adverse event and no harm in this study. Based on our knowledge, the study will not have any negative consequences. Every 6 months, we will send a report to the auditor. We will share the results of this study with key stakeholders via presenting in related seminars and publishing in peer-reviewed journals. We will share the results of this study with key stakeholders via presenting in related seminars and publishing in peer-reviewed journals.
: This manuscript does not contain individual personal data from patients.
: The authors declare that they have no competing interests.