Tambo, Yuichi
Hosomi, Yukio
Sakai, Hiroshi
Nogami, Naoyuki
Atagi, Shinji
Sasaki, Yasutsuna
Kato, Terufumi
Takahashi, Toshiaki
Seto, Takashi
Maemondo, Makoto
Nokihara, Hiroshi
Koyama, Ryo
Nakagawa, Kazuhiko
Kawaguchi, Tomoya
Okamura, Yuta
Nakamura, Osamu
Nishio, Makoto
Tamura, Tomohide
Article History
Received: 5 December 2016
Accepted: 24 January 2017
First Online: 30 January 2017
Compliance with ethical standards
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: This study was supported by Yakult Honsha. The study sponsor contributed to the design of the study, data collection, analysis and interpretation of data, writing of the manuscript, and decision to submit the manuscript for publication. All authors had access to all the data in the study and agreed with the decision to submit for publication.
: Y. Okamura has stock ownership of Yakult. Y. Okamura and O. Nakamura are employees of Yakult. Y. Hosomi has received personal fees from AstraZeneca, Chugai, Eli Lilly, Ono and Taiho. H. Sakai has received grants from Yakult and personal fees from Bristol-Myers Squibb, Chugai, Eli Lilly, Ono and Taiho. N. Nogami has received grants from Yakult and personal fees from Astellas, AstraZeneca, Boehringer Ingelheim, Chugai, Eli Lilly, Ono, Pfizer and Taiho. S. Atagi has received grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chugai, Eli Lilly and Taiho, grants from Merck Serono, Ono, Pfizer and Yakult, and personal fees from Bristol-Myers Squibb. Y. Sasaki has received grants and personal fees from Eisai, Taiho and Yakult, grants from Bristol-Myers Squibb and Novartis, and personal fees from Bayer Yakuhin, Eli Lilly, GlaxoSmithKline, Merck Serono, Nichi-Iko Pharmaceutical, Ono, Sawai and Takeda. T. Kato has received grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chugai, Eli Lilly, Kyowa Hakko Kirin, Ono, Pfizer and Taiho, grants from Abbvie, Astellas, Bristol-Myers Squibb, Daiichi Sankyo, MSD, Parexel, Quintiles, Takeda and Yakult, and personal fees from Roche. T. Takahashi has received grants and personal fees from AstraZeneca, Chugai, Eli Lilly, Ono and Pfizer, grants from MSD, Takeda and Taiho, and personal fees from Boehringer Ingelheim. T. Seto has received grants and personal fees from AstraZeneca, Chugai, Eisai, Eli Lilly, Boehringer Ingelheim, Novartis, Pfizer, Sanofi and Taiho, grants from Astellas, Bayer Yakuhin, Merck Serono, MSD, Verastem and Yakult, and personal fees from Daiichi Sankyo, Fuji Pharma, Hisamitsu, Kyowa Hakko Kirin, Mochida, Nippon Kayaku, Ono, Roche Diagnostics, Showa Yakuhin Kako, Sumitomo Dainippon Pharma and Takeda. H. Nokihara has received grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chugai, Eli Lilly, Ono and Taiho, grants from Astellas, Daiichi Sankyo, Eisai, GlaxoSmithKline, Merck Serono, Novartis, Pfizer, Quintiles and Yakult, and personal fees from Bristol-Myers Squibb and Sanofi. K. Nakagawa has received grants and personal fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Kyowa Hakko Kirin, Ono and Pfizer, grants from Eisai, EPS Associate, MSD, Japan Clinical Research Operations, PPD-SNBL, OncoTherapy Science, Quintiles, Takeda, Taiho, and personal fees from Astellas, Eli Lilly, EPS Holdings, Showa Yakuhin Kako and SymBio Pharmaceuticals. M. Nishio has received grants and personal fees from AstraZeneca, Bristol-Myers Squibb, Chugai, Eli Lilly, Ono, Pfizer and Taiho, and grants from Astellas and Novartis. T. Tamura has received personal fees from Astellas, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Novartis, Ono, Taiho and Yakult. Y. Tambo, M. Maemondo, R. Koyama and T. Kawaguchi have no conflict of interest to disclose.
: This study was performed in accordance with the Declaration of Helsinki and Good Clinical Practice and was approved by the institutional review boards of all participating institutions.
: All patients provided written informed consent before enrollment in this study.