Ethics approval and consent to participate
This trial was approved by the Chiba University Clinical Research Ethical Review Committee (CRB3180015, No. G29027). The participating patients and parents provided written and verbal informed consent using the form and protocol approved by the Chiba University Clinical Research Ethical Review Committee. Following a verbal explanation of the trial, participants completed a consent form distributed by the researchers. All methods were performed in accordance with the relevant guidelines and regulations of the Declaration of Helsinki.