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Article History

Received: 15 April 2024

Accepted: 8 October 2024

First Online: 22 October 2024

Declarations

:

: M.S., V.S., S.M.B., B.S., A.N.M., M.N., and S.E.M. have received educational, research grants, lecture honorarium, travel supports to attend scientific meetings from Biogen, Merck, Bayer, Roche, Novartis, CinnaGen, Osveh, Zistdaru, Zahravi, Nanoalvand, and Genzyme. R.A. has received support for scientific meetings and honorarium for advisory board from CinnaGen, Merck, Roche, Zistdaru, Nanoalvand, Zahravi, Cobel Daru, and Actoverco. F.A. has received educational, research grants, lecture honorarium, travel supports to attend scientific meetings from Biogen, Merck, Bayer, Roche, Novartis, CinnaGen, Osveh, Zistdaru, Zahravi, and Nanoalvand. N.M. has received educational, research grants, lecture honorarium, travel supports to attend scientific meetings from Biogen, Merck, Roche, Novartis, CinnaGen, Osveh, Zistdaru, and Nanoalvand. S.N. has received educational, research grants, lecture honorarium, travel supports to attend scientific meetings from Biogen, Merck, Roche, CinnaGen, Zistdaru, and Nanoalvand. H.G.L. has received educational, lecture honorarium, travel supports to attend scientific meetings from Biogen, Merck, Bayer, Roche, CinnaGen, Zistdaru, Zahravi, Nanoalvand, and Genzyme. N.B. has received travel supports to attend scientific meetings from Biogen, Merck, Bayer, Novartis, CinnaGen, Zistdaru, and Nanoalvand. H.A. has received educational, research grants, lecture honorarium, travel supports to attend scientific meetings from Biogen, Merck, Bayer, Novartis, CinnaGen, Zistdaru, Zahravi, and Nanoalvand. A.N. has received speaker fee to attend scientific meetings from Merck, CinnaGen, Zistdaru, and Nanoalvand. N.R. has received educational, research grants, lecture honorarium, travel supports to attend scientific meetings from Biogen, Merck, CinnaGen, Osveh, Zahravi, and Nanoalvand. E.A. has received payment from CinnaGen for the interpretation of MRI scans. M.G. has declared no competing interests. A.S. is a member of 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. H.K. is the head of the medical department and S.A. is the manager of the clinical research unit of Orchid Pharmed Company; the CinnaGen Company partner in conducting clinical trials.

: This study was performed in line with the principles of the 1964 Declaration of Helsinki and its later amendments, and Good Clinical Practice guidelines. The study was approved by the ethics committees of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1398.164) and Shahid Beheshti University of Medical Sciences (IR.SBMU.REC.1398.024). These ethical approvals covered all the necessary approvals for 15 study centers. Written informed consent was obtained from each individual participant involved in the study. Consent for publication was not applicable in this study.

: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.