Ethical approval
The study protocol, informed consent form, case report form, investigator’s manual, and other related documents were approved by the Medical Ethics Committee of the Children's Hospital of Fudan University (reference number: 2018/135). The study was conducted in compliance with the Declaration of Helsinki and Good Clinical Practices and was approved by the institutional review board of each study site. Informed consent to participate in the study has been obtained from the participant’s legal guardian.