Yuge, Kotaro
Nagamitsu, Shinichiro
Ishikawa, Yuko
Hamada, Izumi
Takahashi, Hiroyuki
Sugioka, Hideyuki
Yotsuya, Osamu
Mishima, Kazuo
Hayashi, Masaharu
Yamashita, Yushiro
Funding for this research was provided by:
Nobelpharma Co., Ltd.
Article History
Received: 13 February 2020
Accepted: 31 August 2020
First Online: 10 September 2020
Ethics approval and consent to participate
: The present clinical trial was conducted in accordance with the Helsinki Declaration of 1975 and competent regulations valid in Japan. The protocol and the related informed consent form were approved by the ethics entities at the following 13 medical institutions for 17 participating medical institutions: research ethics committees at Saitama Children’s Medical Center, Hayashi Diabetes Clinic, National Center for Neurology and Psychiatry, National Center for Child Health and Development, Tokyo Metropolitan Children’s Medical Center, Kurume University, and Osaka City General Hospital; institutional review boards at Yamanashi Prefectural Central Hospital, Seikeikai Hospital, Matsuyama Shimin Hospital, Dokkyo University Saitama Medical Center; the institutional review board at Jimbo Orthopedics that covered Ohno Hagukumi Clinic, Hinomine General Ryoiku Center, and Kumamoto Ezuko Ryoiku Medical Center, and the institutional review board at Mizuo Clinic that covered Yokohama Psycho-Developmental Clinic, Oyamadai Suku-suku Clininc, and Mikuri Kids Clinic.
: Not applicable.
: KY reported receiving grant support from Nobelpharma during the conduct of the study. SN reported receiving grant support from Nobelpharma during the conduct of the study. MH reported receiving consulting fees from Nobelpharma during the conduct of the study. KM reported receiving grans from the Japanese Ministry of Health, Labour and Welfare (H29-Seishin-Ippan-001, 19GC1012), the Japanese Ministry of Education, Science, and Technology, and the National Center of Neurology and Psychiatry Intramural Research Grant for Neurological and Psychiatric Disorders, consulting fees from Nobelpharma and Taisho Pharmaceutical, and lecture fees from Eisai, MSD, Takeda Pharmaceutical, Astellas Pharma, and Janssen Pharmaceutical. MF reported receiving grant support from Nobelpharma. HT is an employee of CMIC HOLDINGS. YI, IH, HS, OY are employees of Nobelpharma. YY reported receiving grant support from Nobelpharma.