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Article History

Received: 27 February 2020

Accepted: 20 May 2020

First Online: 4 June 2020

Compliance with ethical standards

:

: TK has received travel support from Shionogi & Co., Ltd. in relation to this study and grants from Ono Pharmaceuticals, Merck, Sharpe & Dohme, Oncolys BioPharma, Astellas Amgen BioPharma and Chugai, outside the submitted work. KK has received grants from Ono Pharmaceuticals, Merck & Co. and Merck Serono. T Nakatsura undertakes advisory services for Shionogi Co., Ltd. YS has received travel support from Shionogi & Co., Ltd in relation to this study. TM has undertaken speaker’s bureau for Ventana/Roche and Gilead Sciences Ltd., receives royalties relating to patents from DAKO Agilent and has received travel support from Ventana/Roche. TM and IP have a patent pending for a multiplex IHC protocol. TH and SY are employees of Cancer Precision Medicine, Inc., and hold patents that have been licensed to OncoTherapy Science, Inc. T Nakagawa, MF, MN, KS and NI are employees of Shionogi Co., Ltd. HD and TF declare no conflicts of interest.

: Data will be available upon reasonable request and after launching S-588410.

: The ethics committee of the study sponsor, Shionogi & Co., Ltd. (held on March 19, 2016), reviewed the protocol and study documents for ethical and scientific adequacy. This study was conducted in accordance with all appropriate regulatory requirements and under protocol approved by the institutional review board at each site, and complying with the latest Ministerial Ordinance on Good Clinical Practice, all appropriate subject privacy requirements and the ethical principles outlined in the Declaration of Helsinki.