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.