Acknowledgements
The authors thank the patients, their families, the physicians who participated in this study, and the IDMC comprising Hideki Ueno (National Defense Medical College, Saitama, Japan), Taroh Satoh (Osaka University Graduate School of Medicine, Osaka, Japan), and Takeharu Yamanaka (Yokohama City University School of Medicine, Kanagawa, Japan). Medical writing assistance was provided by Sarayu Pai, PhD, CMPP, and Pooja Sagar, PhD, of Cactus Life Sciences (part of Cactus Communications) and funded by Taiho Pharmaceutical Co., Ltd.