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Article History

Received: 31 July 2018

Accepted: 13 June 2019

First Online: 26 June 2019

Ethics approval and consent to participate

: The study was conducted in adherence to the ethical principles that are based on the Declaration of Helsinki, Good Clinical Practice, guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, and applicable laws and regulations. Patients provided written informed consent prior to commencement of the study. The following institutional review boards provided ethical approval for the study: Hokkaido University Hospital, Kyushu University Hospital, Akita City Hospital, Nanko Psychiatric Institute, Mito Medical Center, Seimou Hospital, Shoda Hospital, Adachi Kyosai Hospital, Nippon Medical School Chiba Hokusoh Hospital, Suzuki Hospital, Neuropsychiatric Research Institute, Showa University Karasuyama Hospital, Suzuki Internal Medicine and Cardiology, Akasaka Clinic, Mizuo Clinic, Himorogi Psychiatric Institute, Keihin-chuo Clinic & Hisamitsu Clinic & Masabayashi Clinic, Tokyo-eki Center-building Clinic, Eda Memorial Hospital, Kayaba-cho Dermatology, Minami-toyama Nakagawa Hospital, Japanese Red Cross Society Azumino Hospital, Aichi Medical Association, Yuge Hospital, Asakayama General Hospital, Kindai University Hospital, Kusatsu Hospital, Tokushima University Hospital, Omuta-chuo Hospital, Haradoi Hospital, Yokohama Minoru Clinic, University of the Ryukyus Hospital, Kurayoshi Hospital, Nishigahara Hospital, Arakaki Hospital, Hannan Hospital, Kagawa University Hospital, Yatsushiro-kousei Hospital, Tokyo Shinjuku Medical Center, Nagoya University Hospital, Oita University Hospital, Okayama University Hospital, Fujita Health University Hospital, Hiroshima University Hospital, Hospital of the University of Occupational and Environmental Health, Ashiribetsu Hospital, Riverside Clinic, Minami Sakai Hospital, Keio University Hospital, Tokyo Musashino Hospital, Mitsui Memorial Hospital, Brain Attack Center Ota Memorial Hospital, Hokkaido Study Group of Clinical Psychopharmacology, Okamoto Hospital, Center Hospital of the National Center for Global Health and Medicine, Ongata Hospital, Yamato Mental Medical Center, Sapporo City General Hospital, Hiro Clinic Omori, Japanese Red Cross Medical Center, Negishi Hospital, Nishi Hospital, and Kondou Hospital.

: Not applicable.

: Specific and substantive relationships are as follows: Shigenobu Kanba declares honoraria from MSD K.K., Astellas Pharma Inc., Mochida Pharmaceutical Co., Ltd., Eisai Co., Ltd., Takeda Pharmaceutical Co., Ltd., Dainippon-Sumitomo Pharma Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Taisho-Toyama Pharmaceutical Co. Ltd., Janssen Pharmaceutical K.K., Meiji Seika Pharma Co. Ltd., Yoshitomiyakuhin Co., Nippon Chemiphar Co. Ltd., Daiichi Sankyo Co. Ltd., Pfizer Inc., Shionogi & Co., Ltd., and Mitsubishi Tanabe Pharma Co., and research funding from MSD K.K., Dainippon-Sumitomo Pharma Co. Ltd., Janssen Pharmaceutical K.K., Astellas Pharma Inc., Nippon Chemiphar Co. Ltd., Pfizer Inc., Mochida Pharmaceutical Co. Ltd., Eisai Co., Ltd. Meiji Seika Pharma Co., Ltd., Yoshitomiyakuhin Co., Shionogi & Co., Ltd., and Mitsubishi Tanabe Pharma Co. Mitsukuni Murasaki declares personal fees from Astellas Pharma Inc., Meiji Seika Pharma Co., Ltd., Eli Lilly Japan, Eisai Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., and Janssen Pharmaceutical K.K. Tsukasa Koyama declares personal fees from Astellas Pharma Inc., Eli Lilly Japan, Otsuka Pharmaceutical, and Mitsubishi Tanabe Pharma Co. Masahiro Takeuchi () declares personal fees from Astellas Pharma Inc. Yuriko Shimizu, Eri Arita, Kentaro Kuroishi, Masahiro Takeuchi, and Shinya Kamei are employees of Astellas Pharma Inc.