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Yusuke Yamaguchi is an employee of Astellas Pharma, Inc. Kashia Goto has participated in a company stock ownership plan through Astellas Pharma, Inc. Shaka Martin is an employee of Astellas Pharma, Inc. Alina Jiletcovici has received stock or stock options as a minor shareholder for Eli Lilly and Company and is an employee of Astellas Pharma, Inc. Frank Dellanna has nothing to disclose. Tadao Akizawa has received personal consulting fees from Astellas Pharma, Inc., Kyowa Kirin, Kissei Pharmaceutical, Ono Pharmaceutical, Fuso Pharmaceutical, Torii Pharmaceutical, GlaxoSmithKline, JT Pharmaceutical, Nipro Corporation, Otsuka, Sanwa Kagaku and Bayer and has also received personal payment or honoraria for lectures from Astellas Pharma, Inc., Kyowa Kirin, Kissei Pharmaceutical, Ono Pharmaceutical, Fuso Pharmaceutical I, Torii Pharmaceutical, Chugai Pharmaceutical, Mitsubishi Tanabe, and Bayer. Jonathan Barratt has received fees for invited lectures from Astellas Pharma, Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"All studies included in this post hoc analysis were conducted in accordance with the ethical principles of the Declaration of Helsinki of 1964 and its later amendments, the International Conference on Harmonisation of Technical Requirements for Pharmaceutical for Human Use guidelines, Good Clinical Practice, and applicable local laws and regulations. As this was a pooled post hoc analysis, approval by an ethics committee for this analysis was not necessary; however, institutional review board approval was obtained prior to initiating each of the included studies. All participants provided written informed consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}