Published Online: November 9, 2008 (doi:10.1001/jama.2008.623).
Author Contributions: Dr Morimoto had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Ogawa, Nakayama, Morimoto, Saito.
Acquisition of data: Ogawa, Nakayama, Morimoto, Uemura, Kanauchi, Doi, Jinnouchi, Sugiyama.
Analysis and interpretation of data: Ogawa, Nakayama, Morimoto.
Drafting of the manuscript: Ogawa, Nakayama, Morimoto, Uemura.
Critical revision of the manuscript for important intellectual content: Ogawa, Nakayama, Morimoto, Kanauchi, Doi, Jinnouchi, Sugiyama, Saito.
Statistical analysis: Ogawa, Morimoto.
Obtained funding: Ogawa, Nakayama, Morimoto.
Administrative, technical, or material support: Ogawa, Nakayama, Morimoto, Uemura, Kanauchi, Doi, Jinnouchi, Sugiyama, Saito.
Study supervision: Ogawa, Nakayama.
Financial Disclosures: Drs Ogawa, Nakayama, and Sugiyama reported receiving grant support for the past 5 years from the Ministry of Health, Labour and Welfare (Japan) and grant support and lecturer's fees from Astellas, AstraZeneca, Banyu, Bayer Yakuhin, Boehringer Ingelheim, Cathex, Chugai, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Get Bros, Guidant Japan, Japan Lifeline, Kaken, Kissei, Kowa, Kyowa Hakko, Mitsubishi Tanabe, Mochida, Nihon Kohden, Nihon Schering, Novartis, Otsuka, Pfizer, Pharmacia, Sankyo, Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Schering-Plough, Sionogi, Sumitomo, Taisho Toyama, Takeda, Mitsubishi Tanabe, Teijin, Toa Eiyo, Torii, Toyama, Tyco Healthcare Japan, Vitatron Japan, Zeria, Novo Nordisk, Higo Foundation for Promotion of Medical Education and Research, Japan Foundation of Applied Enzymology, Japan Heart Foundation, Japanese Society of Interventional Cardiology, Kimura Memorial Heart Foundation, Kumamoto Medical Society, Smoking Research Foundation, and Takeda Science Foundation. Dr Saito reported receiving grant support for the past 5 years from the Ministry of Health, Labour and Welfare (Japan) and grant support and lecturer's fees from Astellas, AstraZeneca, Banyu, Bayer, Baxter, Boehringer Ingelheim, Boston Scientific, Chugai, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Fukuda Denshi, Johnson & Johnson, Kirin, Kowa, Kyowa Hakko, Mochida, Nihon Kohden, Novartis, Novo, Ono, Shionogi, Taisyo Toyama, Pfizer, Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Takeda, Mitsubishi Tanabe, Zeria, and Japan Heart Foundation. Dr Morimoto reported being a statistical consultant for the Research Institute for Production Development, a nonprofit research foundation; receiving nonpurpose research grants from Bayer Yakuhin and Daiichi Sankyo; and receiving lecturer's fees from Bayer Yakuhin, Daiichi Sankyo, Dainippon Sumitomo, Kowa, Otsuka, and Pfizer for the past 5 years. Drs Uemura and Kanauchi reported receiving support from the Ministry of Health, Labour and Welfare (Japan) for the past 5 years. Dr Jinnouchi reported receiving honoraria for lectures from Astellas, Banyu, Bayer, Boehringer lngelheim, Daiichi Sankyo, Novartis, Sankyo, Sanofi-Aventis, Takeda, Sanwa Kagaku Kenkyusho, and Novo Nordisk for the past 5 years. No other conflicts were reported.
Funding/Support: This study was supported by the Ministry of Health, Labour and Welfare of Japan.
Role of the Sponsor: The funding source had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators: Hisao Ogawa (principal investigator). Steering Committee: Yoshihiko Saito (chair), Masafumi Nakayama, Masao Kanauchi, Shiro Uemura, and Takeshi Morimoto (study statistician). Committee on Validation of Data and Events: Izuru Masuda (chair), Dr Nakayama, and Dr Kanauchi. Safety Monitoring Board: Hirotsugu Ueshima (chair), Hiroo Imura, and Kazuo Kimura. Independent Data Management Center: Makiko Ohtorii and Eri Miyake.
Investigators: Hideaki Jinnouchi, Yoichi Hanaoka, Masako Waki, Kyousuke Kawamura, Michio Shimabukuro, Kimiaki Nishiura, Takahiro Kawano, Yusuke Kyoda, Jun Hashiguchi, Tadashi Kagoshima, Masakazu Hanatani, Norihiko Matsumura, Naofumi Doi, Kenji Nakai, Yoshiyuki Kobayashi, Megumi Suzuki, Tsuneari Soeda, Yoshinobu Morikawa, Masashi Horimoto, Atsushi Hasegawa, Shigeru Yamano, Syuichi Matsuo, Yasuhiro Sakamoto, Izuru Masuda, Akiko Yasuno, Yuriko Fujinaga, Kazuko Horii, Takeshi Koga, Hiroshi Ogawa, Ken Ozaki, Makoto Ikemura, Motomu Hayashi, Ikuo Yabuta, Kiyotaka Sughihara, Akihiro Yazaki, Joji Masuda, Yoshiharu Nishitani, Masaki Naito, Shigenobu Ote, Kazuhiko Yamada, Chikashi Wakabayashi, Yoshiaki Fukuoka, Keiji Mahara, Hirofumi Kan, Eiji Oshima, Toshio Sutani, Koichi Hoda, Koryo Sawai, Kenichi Yamaga, Tomoki Nakamura, Shinya Okamoto, Hiroaki Horie, Kenichi Ashihara, Hiroshi Miki, Hisaharu Makino, Takafumi Odo, Yoshihisa Iseri (retired in 2007), Hiroyuki Tanaka, Kousuke Marutsuka, Akira Nakatani, Hironori Murakami, Yoshiko Shioya, Yutaka Horio, Tsuneo Ikeda, Kazuo Machii, Masanori Kamura, Keiichiro Ban, Yoshihiro Fujii, Kazuo Nishimoto, Susumu Misugi, Tetsuo Munakata, Katsutoshi Yoshimura, Shigetoshi Minami, Takao Nakashima, Hirofumi Ogata, Atuko Hifumi, Nobuko Sakurai, Ryuichiro Tsurusaki, Yoshito Yamanaka, Hiromitsu Yokota, Seishi Ichihara, Motoki Yoshinari, Yoko Sawada, Eiji Kawashima, Kazuo Goto, Yoshimi Kinoshita, Masao Kikukawa, Hiroharu Yamada, Yuya Tanaka, Mayumi Kiyota, Yoshihiro Kimura, Yasuhiro Morikami, Masahiro Fukuda, Takeshi Takami, Fumihiko Nakatani, Shojiro Naomi, Toshiaki Nasu (retired in 2006), Tomohiro Sawada, Fuyuki Minagawa, Osamu Haraguchi, Norifumi Kondo, Hiroyuki Shono, Hiromichi Sugiyama, Takeshi Matsuo, Minoru Takaoka, Tamio Nakajima, Masamitsu Toihata, Kozaburo Matsuyama, Kenichi Komori, Toshio Tsubokura, Madoka Taguchi, Yuko Hiramori, Hiroto Okubo, Akihiro Iemura, Osamu Doi, Masayuki Ogihara, Kenji Misumi, Koji Seo, Ken Iwai, Masatoshi Naito, Seiji Ozawa, Kotaro Minoda, Hiromi Fujii, Kimiaki Miwa, Genshi Egusa, Isao Yasuda, Michiaki Ueda, Junichi Miyata, Midori Yoshimura, Masakuni Uemyama, Katumi Watanabe, Yoshikuni Haraguchi, Satoshi Tanazawa, Yoshiaki Osamura, Junji Shibata, Takashi Ono, Syuichi Kamijikkoku, Kazumi Yoshimoto, Etsuo Kinuwaki, Kazuo Kozuma, Kenji Onoue, Yukitaka Nakano, Nanami Abe, Haruo Araki, Kyoji Takaoka, Chieko Imamoto, Hisakazu Suefuji, Keisuke Sugimoto, Terufumi Matsunaga, Akiko Oya, Yoko Onishi, Keizo Kajiwara, Tetsuo Ikuno, Michiaki Doi, Toshiro Igaki, Hiroshi Bando, Tateo Ogura, Kenichi Doijiri, Taisuke Iwaoka, Kazunobu Akahoshi, Kenji Obata, Hisashi Shimono, Kaoru Tsuda, Shinya Yumoto, Keishiro Oka, Hironori Hasegawa, Hisao Fujimoto, Toshiya Atsumi, Akira Matsutani, Yohiyuki Katsuyama, Ryo Fukami, Yoshihisa Iseri, Yutaka Ishibashi, Kiyotaka Kudou, Tetsuo Kuwahara, Kazutaka Maeda, Akira Maki, Naoki Manda, Hirofumi Yasue, Yuji Mizuno, Sueo Momosaki, Koji Tokube, Fumishi Tomita, Tatsuaki Tsuchiya, Matahiro Yabuta, Hidei Yamada, Seigo Sugiyama.
Additional Contributions: Proofreading support and assistance was provided by Fred Robin and Julie Gerke, ELS, of Innovex (a division of Quintiles Transnational that received funding from Kumamoto University).