Acknowledgements
The authors thank the patients and their families, the study investigators, and the study-site personnel for their participation and contribution to this study. We also thank Eshvendar Reddy Kasala, PhD, CMPP™ of Novartis Healthcare Pvt. Ltd., Hyderabad, India for providing writing support in accordance with Good Publication Practice (GPP) guidelines, which was funded by Novartis Pharmaceuticals Corporation.