Ethics approval and consent to participate
The ethical committees of the participating institutions approved the study protocol. All participants provide written informed consent before date collection. The protocol was registered in the University Hospital Medical Information Network Clinical Trials Registry
(UMIN000012950, UMIN000012951, UMIN000012952, and UMIN000003409)
Consent for publication
Not applicable
Availability of date and material
Not applicable
Competing interests
The authors declared that they do not have anything to disclose regarding conflict of interest with respect to this manuscript
Funding sources
Grant-in-Aid for Scientific Research from the Ministry of Education, Science and Culture of Japan (18590815 and 21590898 to Y.Higashi) and a Grant-in-Aid of Japanese Arteriosclerosis Prevention Fund (to Y.Higashi).
Author’s contributions
T.Y. and Y.Higashi, drafting the article and conception of the study; T.H., Y.Hashimoto, Y.T., M.K., Y.Han, T.M., S.K., T.H., C.G., Y.A., A.N., and F.M.Y. acquiring subjects and/or data; E.H., K.C. and Y.K., revising the article critically for important intellectual content. Y.Higashi is the guarantor of this work and, as such, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of data analysis.
Acknowledgments
The authors would like to thank all of the patients who participated in this study. In addition, we thank Miki Kumiji, Megumi Wakisaka, Ki-ichiro Kawano and Satoko Michiyama for their excellent secretarial assistance; FMD-J investigators Takayuki Hidaka, MD, PhD; Shuji Nakamura, MD, PhD; Junko Soga, MD, PhD; Yuichi Fujii, MD, PhD; Naomi Idei, MD; Noritaka Fujimura, MD, PhD; Shinsuke Mikami, MD, PhD; Yumiko Iwamoto, MD; Akimichi Iwamoto, MD, PhD; Takeshi Matsumoto, MD, PhD; Nozomu Oda, MD, PhD (Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical Sciences, Hiroshima, Japan); Kana Kanai, PhD; Haruka Morimoto, PhD (Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan); Tomohisa Sakashita, MD, PhD; Yoshiki Kudo, MD, PhD (Department of Obstetrics and Gynecology, Hiroshima University Graduate School of Biomedical Sciences, Hiroshima, Japan); Taijiro Sueda, MD, PhD (Department of Surgery, Hiroshima University Graduate School of Biomedical Sciences, Hiroshima, Japan); Hirofumi Tomiyama, MD, PhD, FAHA; Akira Yamashina, MD, PhD (Department of Cardiology, Tokyo Medical University, Tokyo, Japan); Bonpei Takase, MD, PhD, FAHA (Division of Biomedical Engineering, National Defense Medical College Research Institute, Tokorozawa, Japan); Takahide Kohro, MD, PhD (Department of Cardiology, Tokyo Medical University, Tokyo, Japan); Toru Suzuki, MD, PhD (Cardiovascular Medicine, University of Leicester, Leicester, UK); Tomoko Ishizu, MD, PhD (Cardiovascular Division, Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan); Shinichiro Ueda, MD, PhD (Department of Clinical Pharmacology and Therapeutics, University of the Ryukyu School of Medicine, Okinawa, Japan); Tsutomu Yamazaki, MD, PhD (Clinical Research Support Center, Faculty of Medicine, The University of Tokyo, Tokyo, Japan); Tomoo Furumoto, MD, PhD (Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Hokkaido, Japan); Kazuomi Kario, MD, PhD (Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan); Teruo Inoue, MD, PhD (Department of Cardiovascular Medicine, Dokkyo Medical University, Mibu, Tochigi, Japan); Shinji Koba, MD, PhD (Department of Medicine, Division of Cardiology, Showa University School of Medicine, Tokyo, Japan); Kentaro Watanabe, MD, PhD (Department of Neurology, Hematology, Metaboism, Endocrinology and Diabetology (DNHMED), Yamagata University School of Medicine, Yamagata, Japan); Yasuhiko Takemoto, MD, PhD (Department of Internal Medicine and Cardiology, Osaka City University Graduate School of Medicine, Osaka, Japan); Takuzo Hano, MD, PhD (Department of Medical Education and Population-based Medicine, Postgraduate School of Medicine, Wakayama Medical University, Wakayama, Japan); Masataka Sata, MD, PhD (Department of Cardiovascular Medicine, Institute of Health Biosciences, The University of Tokushima Graduate School, Tokushima, Japan); Yutaka Ishibashi, MD, PhD (Department of General Medicine, Shimane University Faculty of Medicine, Izumo, Japan); Koichi Node, MD, PhD (Department of Cardiovascular and Renal Medicine, Saga University, Saga, Japan); Koji Maemura, MD, PhD (Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan); Yusuke Ohya, MD, PhD (The Third Department of Internal Medicine, University of the Ryukyus, Okinawa, Japan); Taiji Furukawa, MD, PhD (Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan); Hiroshi Ito, MD, PhD (Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan); and Hisao Ikeda, MD, PhD (Faculty of Fukuoka Medical Technology, Teikyo University, Omuta, Japan).