Funding for this research was provided by:
Dainippon Sumitomo Pharma
Received: 27 February 2021
Accepted: 29 June 2021
First Online: 2 August 2021
: The 6 week double-blind study, the subsequent long-term extension phase, and the study recruiting patients with a manic, hypomanic, or mixed episode directly into a 52 week long-term treatment period, were each reviewed and approved by institutional review boards at each investigational site. The studies were conducted in accordance with the International Conference on Harmonization Good Clinical Practices guidelines and with the ethical principles of the Declaration of Helsinki. All patients reviewed and signed an informed consent document explaining study procedures and potential risks prior to enrollment in the 52 week long-term treatment study.
: All authors consent to the publication of the manuscript in International Journal of Bipolar Disorders.
: <i>Teruhiko Higuchi</i> 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. <i>Tadafumi Kato</i> reports personal fees from Kyowa Hakko Kirin, Eli Lilly, Otsuka Pharmaceutical, GlaxoSmithKline, Taisho Toyama Pharmaceutical, Sumitomo Dainippon Pharma, Meiji Seika Pharma Pfizer, Mochida Pharmaceutical, Shionogi, Janssen Pharmaceutical, Janssen Asia Pacific, Yoshitomiyakuhin, Astellas Pharma, Wako Pure Chemical Industries, Wiley Publishing Japan, Nippon Boehringer Ingelheim Kanae Foundation for the Promotion of Medical Science, MSD, Kyowa Pharmaceutical, and Takeda Pharmaceutical, and also reports a research grant from Takeda Pharmaceutical. <i>Mari Miyajima, Kei Watabe, Takahiro Masuda,</i> and <i>Katsuhiko Hagi</i> are full-time employees of Sumitomo Dainippon Pharma Co., Ltd. <i>Jun Ishigooka</i> reports grants from Sumitomo Dainippon during the conduct of the study, personal fees from Meiji Seika Pharma, MSD, Astellas, Novartis, Pfizer, Otsuka, Eli Lilly, Takeda, and Eisai.