Acknowledgments
Authors would like to tell the appreciation to Ayako Kanie MD, PhD for general administrative support and recruiting participants, Yukiko Hanada MA and Eriko Mizokawa MA for coordinating the trial, Asami Komazawa PhD, Chiaki Nakayama PhD, Ryo Horita PhD for collecting data, Naotsugu Hirabayashi MD, PhD, Fumi Imamura MA, Haruka Matsuda MD, Nahoka Kobayashi MD, Aiichiro Nakajima MD, PhD, Yasue Mitamura MD for recruiting participants, Tsunakuni Ikka, PhD, Kazushi Maruo, PhD, and Norio Sugawara PhD for consulting the change of protocol regarding the re-estimation of needed sample size, Kyoko Akutsu for managing data set and conducting on-site monitoring, Koki Takagaki, PhD, for reviewing the minutes of blinded interpretation, and Ono Yutaka MD, PhD, and Atsuo Nakagawa MD, PhD, for serving as a member of data and safety monitoring boards. The authors respectfully would like to show appreciation to participants for their effort to participate in the trial.