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Article History

Received: 8 November 2023

Accepted: 22 January 2024

First Online: 1 February 2024

Declarations

:

: This clinical trial is conducted in accordance with the Declaration of Helsinki and the relevant Chinese clinical trial research norms and regulations. Prior to the start of the trial, the clinical trial protocol and its amendment application, CRF, and informed consent form shall be approved in writing by the Ethics Committee of Kunshan First People’s Hospital before implementation. Plans for notification of any changes to the protocol: first, the sponsor will be notified, and then the PI will notify the centers and that a copy of the revised protocol will be sent to the PI to add to the Investigator Site File. Any deviations from the protocol will be fully documented using a breach report form. Update the protocol in the Clinical Trial Registry. Before each subject is enrolled in the trial, the investigator shall provide a complete and comprehensive introduction to the purpose of the study, the procedures, and the benefits and possible risks of participating in the trial. The investigator obtains a signed and dated informed consent form from both parties prior to the trial. The clinical trial has been approved by the Independent Ethics Committee of Kunshan First People’s Hospital (Number: 2022-03-032-K01). The results of the clinical trial will be disseminated in the form of a manuscript, although the specific publication venue and timeline have yet to be determined. All relevant data and information will be made publicly available upon publication of the manuscript.

: Not applicable.

: The authors declare that they have no competing interests.