Published Online: November 17, 2014. doi:10.1001/jama.2014.15690.
Study concept and design: Ikeda, Shimada, Teramoto, Uchiyama, Yamazaki, Oikawa, Sugawara, Ando, Ishizuka.
Acquisition, analysis, or interpretation of data: Shimada, Uchiyama, Yamazaki, Murata, Yokoyama, Ishizuka.
Drafting of the manuscript: Ikeda, Teramoto, Sugawara, Murata, Ishizuka.
Critical revision of the manuscript for important intellectual content: Ikeda, Shimada, Uchiyama, Yamazaki, Oikawa, Sugawara, Ando, Yokoyama, Ishizuka.
Statistical analysis: Yamazaki, Ishizuka.
Obtained funding: Ikeda, Shimada, Sugawara.
Administrative, technical, or material support: Ikeda, Oikawa, Sugawara, Murata, Yokoyama.
Study supervision: Shimada, Teramoto, Uchiyama, Oikawa, Ando.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ikeda reports receiving fees for medical advice from AstraZeneca, Bayer, Daiichi Sankyo, GlaxoSmithKline, and sanofi-aventis. Dr Shimada reports receiving personal fees from Bayer, Daiichi Sankyo, Dainihon-Sumitomo, MSD, Novartis, Omron, and Takeda. Dr Teramoto reports receiving grant support and personal fees from Amgen, Aska, Astellas, Bayer, Daiichi Sankyo, Kissei, Kobayashi, MSD, and Pfizer. Dr Uchiyama reports receiving grant support and honoraria from Bayer, Boehringer Ingelheim, Daiichi Sankyo, Otsuka, and sanofi-aventis for consultancy and participating in advisory boards. Dr Yamazaki reports receiving grant support from AstraZeneca, Daiichi Sankyo, Dainippon Sumitomo, Kowa, Kyowa Hakko Kirin, MSD, Mitsubishi Tanabe, Pfizer, and Takeda and other fees from AstraZeneca, Daiichi Sankyo, Dainippon Sumitomo, Kowa, Merck Sharp & Dohme, Mitsubishi Tanabe, Mochida, Novartis, sanofi-aventis, Shionogi, Pfizer, and Takeda. Dr Ando reports receiving grant support from Boehringer Ingelheim and Daiichi Sankyo, and fees for participating in speaker bureaus for Astellas, Boehringer Ingelheim, Daiichi Sankyo, J-Milk, Mochida, and Pfizer. Dr Murata reports receiving grant support from Daiichi Sanko and sanofi-aventis and personal fees from Pfizer. Dr Yokoyama reports receiving grant support from Bristol-Myers Squibb, Chugai Seiyaku, Nihon Shinyaku, and Pfizer, and personal fees from Celegene, Chugai Seiyaku, Janssen, Nihon Shinyaku, and Novartis. Dr Ishizuka reports being a former employee of sanofi-aventis. No other disclosures were reported.
Funding/Support: The Japanese Primary Prevention Project (JPPP) was sponsored by the Japanese Ministry of Health, Labor, and Welfare and the Waksman Foundation of Japan. Enteric-coated 100 mg aspirin tablets were provided free of charge by Bayer Yakuhin.
Role of the Funder/Sponsor: The Japanese Ministry of Health, Labor, and Welfare and the Waksman Foundation of Japan had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Takuro Shimbo, MD (Ohta Nishinouchi Hospital, Fukushima), for his advice throughout this study. Dr Shimbo did not receive any compensation. Editorial assistance was provided by Tom Potter, MSc, and Jesse Alderson, PhD (both from Oxford PharmaGenesis Ltd, Oxford), with funding from the JPPP study office.