ACKNOWLEDGEMENTS
The authors thank all the volunteers and their families. The study was funded by EA Pharma Co., Ltd. (Tokyo, Japan) and Kissei Pharmaceutical Co., Ltd. (Matsumoto, Japan). We thank inVentiv Health (Currently Syneos Health, Tokyo, Japan) and Toray Research Center, Inc. (Tokyo, Japan) for the pharmacokinetics analysis. We would also like to thank Yuki Mukaida (EA Pharma Co., Ltd) and PPD-SNBL K. K. for data management and statistical analysis. Medical writing support for the development of this manuscript under the direction of the authors was provided by Tetsuji Asao, PhD (SunFlare Co., Ltd., Tokyo, Japan), which was funded by EA Pharma Co., Ltd. and Kissei Pharmaceutical Co., Ltd.