Acknowledgements
We thank the patients and their families, investigators, and staff from all the participating sites. We thank Satrupa Das, PhD, and Amrita Dutta, PhD, of Novartis Healthcare Pvt. Ltd. for providing medical editorial assistance with this manuscript.
Ethical approval
The study was conducted in accordance with the Good Clinical Practice guidelines and the guiding principles of the Declaration of Helsinki. The institutional review board or ethics committee of each participating center reviewed the protocol.
Informed consent disclosure
All patients were required to provide written informed consent prior to enrolling in the study.
Disclosure statement
Disclosure forms provided by the authors are available online.
Data availability
All data generated or analyzed during this study are included in this published article.