Iwata, Nakao http://orcid.org/0000-0003-3189-6076
Ishigooka, Jun http://orcid.org/0000-0003-0547-2843
Naoi, Ichiro http://orcid.org/0000-0001-6274-9584
Matsumoto, Masahiro http://orcid.org/0000-0001-8086-2281
Kanamori, Yuichi http://orcid.org/0000-0003-2867-1810
Nakamura, Hiroshi http://orcid.org/0000-0001-7699-9840
Higuchi, Teruhiko http://orcid.org/0000-0001-6074-0068
Funding for this research was provided by:
Sumitomo Dainippon Pharma Co., Ltd.
Article History
First Online: 27 December 2019
Compliance with Ethical Standards
:
: The study protocol was approved by the institutional review boards of all participating institutions. This study was also conducted in compliance with the ethical principles stated in the Declaration of Helsinki and with the Good Clinical Practice (GCP) guidelines and other relevant Japanese regulations.
: Written informed consent was obtained from all patients or legal guardians (if the patient was < 20 years old or was hospitalized for medical care and protection) prior to the study based on institutional guidelines.
: This study was funded by Sumitomo Dainippon Pharma Co., Ltd. The open access fee was also paid by Sumitomo Dainippon Pharma Co., Ltd.
: NI reports personal fees from Otsuka, Sumitomo Dainippon, Janssen, Eli-Lilly, and Pfizer and grants from Otsuka and Daiichi-Sankyo outside the submitted work. JI reports grants from Sumitomo Dainippon during the conduct of the study and personal fees from Meiji Seika Pharma, MSD, Astellas, Novartis, Pfizer, Otsuka, Eli Lilly, Takeda, and Eisai outside the submitted work. TH reports personal fees from Meiji Seika Pharma, MSD, Allergan, Eisai, Pfizer, Janssen, Lundbeck, Shionogi, Yoshitomi, Kyowa Hakko Kirin, Mochida, Otsuka, Sumitomo Dainippon, Mitsubishi Tanabe, Eli Lilly, and Takeda outside the submitted work. IN, MM, YK, and HN are employees of Sumitomo Dainippon Pharma Co., Ltd.