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Article History

First Online: 18 July 2019

Compliance with Ethical Standards

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: The study protocols and related documents were reviewed and approved by the respective Institutional Review Boards of Worldwide Clinical Trials in Study I and Osaka Pharmacology Clinical Research Hospital in Study II. Both studies were conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines, the Pharmaceutical Affairs Law, and relevant guidance for each country, and the ethical principles of the Declaration of Helsinki. Study I was registered at ClinicalTrials.gov under the identifier NCT03699774. Study II was registered at the Japan Pharmaceutical Information Center under the identifier JapicCTI-152878.

: All participants provided written informed consent before study enrollment.

: Study I and Study II were supported by Daiichi Sankyo Inc. and Daiichi Sankyo Co., Ltd, respectively.

: Y Maekawa, M Kato, Y Myobatake, E Kamiyama, A Watanabe, K Shiosakai, T Taguchi, and H Ishizuka are employees of Daiichi Sankyo Co., Ltd, and J Zhou is an employee of Daiichi Sankyo Inc. V Dishy, V Warren, and V Vashi were employees of Daiichi Sankyo Inc. during the conduct of the study. Y Maekawa, Y Myobatake, E Kamiyama, A Watanabe, T Taguchi, V Vashi, and H Ishizuka hold stock in Daiichi Sankyo Co., Ltd. H Furuie and R Bass have no conflicts of interest to declare.