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Article History

Received: 23 October 2024

Accepted: 30 January 2025

First Online: 12 February 2025

Declarations

:

: Ethics approvals for this study has been achieved from Research Ethics Committee of Iran University of Medical Sciences by the following case number: IR.IUMS.REC.1402.03.

: The study was performed in accordance with Good Clinical Practice (GCP) guidelines and the Declaration of Helsinki. Each participant signed a written informed consent form before the initiation of the trial.

: This clinical trial has been registered in ClinicalTrials.gov (NCT06137092).

: Aziz Eghbali received educational/research grants and travel supports to attend scientific meetings from Cinnagen (in addition to lecture honorarium), Baxter, and CSL. Peyman Eshghi has received: educational/research grants from Cinnagen (in addition to lecture honorarium), Biotest, Baxter, Novonordisk, and Pfizer. Moreover, he received travel supports to attend scientific meetings from all of the above and CSL. Samin Alavi has received research grant from Cinnagen and travel support from Baxter to attend a scientific meeting. Zahra Badiei has received educational/research grants and lecture honorarium from Cinnagen. Moreover, she received travel supports to attend scientific meetings from Baxter, Novo Nordisk, CSL, and Cinnagen. Mohammadreza Bordbar has received lecture honorarium and travel support to attend scientific programs from Novartis and Aryogen Pharmed Company. Hamidreza Kafi is head of the Medical Department of Orchid Pharmed Company, which is in collaboration with AryoGen Pharmed Company with respect to conducting clinical trials. Moreover, Araz Sabzvari is a member of the CinnaGen Medical Biotechnology Research Center, which collaborates with universities and researchers all over the world with regards to research and development of medications and health issues. Other contributors declared no related conflict of interest to this study.