Akama, Fumiaki
Mikami, Katsunaka
Orihashi, Yasushi
Takase, Syunya
Hanawa, Kyuta
Nishikawa, Keita
Watanabe, Natsuru
Kimoto, Keitaro
Takahashi, Yuki
Onishi, Yuichi
Salas, Juan
Yamamoto, Kenji
Ueno, Shigeru
Article History
Accepted: 20 December 2023
First Online: 24 January 2024
Declarations
:
: Fumiaki Akama has received a Grant-in-Aid for Scientific Research (C) (Number 21K11372) and financial support from Otsuka Pharmaceutical and Shionogi & Co. and honoraria from Eisai Co, Pfizer, Shionogi & Co., and Sumitomo Pharma. Katsunaka Mikami has received a Grant-in-Aid for Scientific Research (C) (Number 22K07624) and financial support from Otsuka Pharmaceutical Co., Ltd., and Shionogi & Co., Ltd.; honoraria from Otsuka Pharmaceutical Co., Ltd., Shionogi & Co., Ltd., Sumitomo Pharma Co., Ltd., and Takeda Pharmaceutical Co., Ltd.; travel expenses for the spouse from Pfizer; and a consulting fee from Otsuka Pharmaceutical Co., Ltd., Shionogi & Co., Ltd., and Viatris. Yasushi Orihashi received consulting fees from the Association of Medical Education and Ethics, Kitasato Clinical Research Center, and Daiichi Sankyo Co. Natsuru Watanabe received Grant-in-Aid for Early-Career Scientists (Number 19K17072). Keitaro Kimoto reports grants and personal fees from Otsuka Pharmaceutical Co., Ltd., and Shionogi & Co., Ltd, honoraria from Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharma Co., Ltd, and Viatris. Yuki Takahashi reports grants and personal fees from Shionogi & Co. Yuichi Onishi has received honoraria from Takeda Pharma Co., Ltd. Kenji Yamamoto reports grants and personal fees from Eisai Co., Ltd., grants and personal fees from Otsuka Pharmaceutical Co., Ltd., personal fees from Meiji Seika Pharma Co., Ltd., personal fees from Sumitomo Dainippon Pharma Co., Ltd., personal fees from Pfizer Japan Inc., personal fees from Mitsubishi Tanabe Pharma Corporation, personal fees from Shionogi & Co., Ltd, personal fees from Eli Lilly and Company, personal fees from EA Pharma Co., Ltd., personal fees from Merck Sharp & Dohme, personal fees from Viatris Inc., personal fees from Astellas Pharma Co., Ltd., personal fees from Shionogi & Co., Ltd., personal fees from Takeda Pharma Co., Ltd., grants from Grants-in-Aid for Scientific Research (C), outside the submitted work. Syunya Takase, Kyuta Hanawa, Keita Nishikawa, Juan Salas, and Shigeru Ueno had no conflict of interest.
: This research consisted of two clinical studies. The first cross-sectional study was approved by the Institutional Review Board for Clinical Research at Tokai University School of Medicine (ref, #13R-106). The next follow-up study was also approved by the Institutional Review Board for Clinical Research at Tokai University School of Medicine (ref, # 20R-394).
: While we planned to obtain written consent from children ≥ 12 years, the maximum age of the participants was 10 years; therefore, written consent was obtained from guardians.
: Not Applicable.