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Article History

Accepted: 3 November 2024

First Online: 13 December 2024

Declarations

:

: This study was funded by MEDICE Arzneimittel Pütter GmbH & Co. KG. Open access publication was also funded by MEDICE Arzneimittel Pütter GmbH & Co. KG. No funding was received to assist with the preparation of this manuscript.

: Yi Zheng, Huaqing Liu, Xiuxia Wang and Haibo Li have no conflicts of interest to declare in relation to this work. Michaela Ruhmann, Anke Mayer and Oliver Dangel are employees of MEDICE Arzneimittel Pütter GmbH & Co. KG. Richard Ammer is managing owner of MEDICE Arzneimittel Pütter GmbH & Co. KG.

: The study protocol, amendments and informed consent form were reviewed and/or approved by Independent Ethics Committees (ECs) according to local regulations before study initiation for each participating study site: Beijing Anding Hospital of Capital Medical University [submission acceptance no.: (2018)clinical review No.(08)], Peking University Sixth Hospital [no.: (2018)ethics review No.(21)], Children’s Hospital of Fudan University [no.: (2018)ethics review No.(192)], The second Xiangya Hospital of Central South University [no.: (2018)ethics review (drug) No.(092)], The First Hospital of Peking University [EC review no.: (2018)drug register No.(36)], Renmin Hospital of Wuhan University [approval no.: WDRY2018-Y054], Beijing Huilongguan Hospital [no.: 2018-28], Children’s Hospital of Shanxi [approval no.: IRB-YL-2018-003], Jiangxi Provincial Children’s Hospital [EC approval no.: PJ2018019], Xiangya Hospital Central South University [no.: Ethics review expedited No.(201809130)], Guangzhou Huiai Hospital [approval no.: (2018) No.(016)], The second affiliated Hospital of Shantou University Medical college [no.: (2018)ethics review No.(6)], Hunan provincial Children’s Hospital [EC approval no.: HNSETYYLL2018001], Guangzhou Women and Children’s Medical Center [no.: GCP (IEC) Approval [2018] No.10], The second affiliated Hospital of Xinxiang University [no.: 2018 ethics review (drug) No.2], The first affiliated Hospital of Jilin University [no.: 18Y164-002], The second Hospital of Hebei Medical University [project no.: 2018EC07-01-1], Children’s Hospital Capital Institute of Pediatrics [base drug (ethics) review no.: [2018]-004], The Second Affiliated Hospital & Yuying Children’s Hospital of Wenzhou Medical University [EC approval no.: drug ethics review No.(2020-041)]. The study was conducted in accordance with the Declaration of Helsinki and its later amendments, the International Council for Harmonization Guideline for Good Clinical Practice, and local regulations.

: All parents/guardians and patients aged 8 to <18 years provided written informed consent before screening.

: Not applicable.

: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

: Not applicable.

: YZ, AM, OD and RA participated in the conception and design of the study. YZ served as principal investigator for the study. YZ, HL, XW and HL contributed to data collection. All authors contributed to interpretation of data. MR drafted the manuscript. All authors have read and approved the final submitted manuscript and agree to be accountable for the work.