Acknowledgements
The authors thank the patients of this study and their families. All authors meet the International Committee of Medical Journal Editors criteria for authorship for this article and take responsibility for the integrity of the work, the data, and its accuracy. All authors had full access to the data in this study and take complete responsibility for the integrity of the data and the accuracy of the data analysis.All authors confirm that they contributed to the scientific content of this paper and meet the following four requirements: (a) significantly contributed to the conception and study design, data acquisition, or data analysis and interpretation; (b) drafted or revised the article for scientific content; (c) gave final approval for the published article; and (d) are accountable for all aspects of the work, ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Medical writing assistance was provided by Ritu Guglani, MD, and Raghuraj Puthige, PhD of ENAGO Life Sciences, India, funded by Daiichi Sankyo Co., Ltd. This study was sponsored by Daiichi Sankyo Co., Ltd. The sponsor provided oversight of the clinical operations, data management, medical monitoring, drug supply, statistical analysis, drug safety process, medical writing, and journal article processing fees.