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Article History

Received: 8 August 2024

Accepted: 2 January 2025

First Online: 8 April 2025

Declarations

:

: The study was approved by the following Institutional Review Boards with their reference numbers listed. Written, informed consent to participate will be obtained from all participants and their parents or legal guardians.

: In accordance with Article 10 (Ownership and Publication of Study Results) of the Clinical Trial Agreement, all tangible and intangible results, including intellectual property rights arising from this study, are owned by the Sponsor. The Institution acknowledges that any publication or public disclosure of study results shall be made solely at the discretion of the Sponsor. Prior to presenting or publishing any study results, data, or findings from this study through academic journals, conferences, or other forums, the Institution or the principal investigator shall submit all presentation or publication materials to the Sponsor for review at least 1 month before the scheduled presentation or publication date. The Institution and the principal investigator agree that any presentation or publication of study results shall occur only within the scope agreed upon in writing by the Sponsor. Additionally, the Institution and the principal investigator shall mention the Sponsor’s financial support in any presentation or publication of the study results, as requested by the Sponsor.The Sponsor may also use the content of any presentation or publication for promotional, advertising, or press release purposes.

: The authors declare that they have no competing interests.