ACKNOWLEDGEMENTS
The authors thank all the volunteers and their families. The study was
funded by EA Pharma Co., Ltd. We thank Toray Research Center, Inc.
(Tokyo, Japan) for the PK 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. (Tokyo, Japan) and Kissei Pharmaceutical Co.,
Ltd. (Matsumoto, Japan).