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Article History

Received: 13 April 2026

Accepted: 24 July 2026

First Online: 8 August 2026

Declarations

Conflict of interest: Caifeng Li, Junmei Zhang, Meiping Lu, Haiguo Yu, Li Sun, Qihua Feng, and Zhihui Li have nothing to disclose. Jane Chen and Haomin Qiu are employed by GSK and hold financial equities in GSK. Tiantian Liu is employed by GSK. Junyi Wu was employed by GSK at the time of the study and holds financial equities in GSK. Xuan Zhou was employed by GSK at the time of the study. This study is independent of the current affiliations for Junyi Wu and Xuan Zhou, with no further conflicts of interest.

Ethical approval: This study was approved by all relevant institutional review boards (IRBs) or ethics committees and was conducted in accordance with the Declaration of Helsinki 2008 and its later amendments, Council for International Organisation of Medical Sciences (CIOM) International Ethical Guidelines, applicable International Organisation for Standardisation 14155 medical device guidelines, the European Medical Device Regulation 2017/745 for clinical device research and other applicable laws and regulations. The master ethics committee was the Medical Ethics Committee of Beijing Children’s Hospital, and all participating IRBs or ethics committees are listed in Table S2. Patients and their legal representatives were informed that study participation was voluntary. Prior to study enrolment, investigative sites obtained signed informed consent from patients or their legally authorized representative that met the requirements of 21 Code of Federal Regulations 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act requirements, where applicable, and the IRB/Independent Ethic Committee (IEC) or study centre.