Ethics approval and consent to participate
The research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki International Conference on Harmonisation Good Clinical Practice, patient privacy requirements, and ethical principles outlined in the Declaration of Helsinki 2018, and was first approved by IRB (reference number: UW 09-254) on the protocol v1 dated 15 June 2009. Health authority approval was obtained per local regulations. Patients provided informed consent according to local requirements.
Consent for publication:
Not applicable
Availability of data and materials
“Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymised to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.”
Competing interests
KHY reports personal fees from Ono Pharmaceutical Co. Ltd., Boehringer Ingelheim, Takeda, BMS, MSD, Eli Lilly, and Amgen, during the conduct of the study; HR reports grants from Novartis, during the conduct of the study; ML and CS are Novartis employees; SY, HD, IS, YMS, YSS, NFA, SS, AS, PFY, CH, HYL, VB, GA, LYB, TJC, TLH, declare that they have no competing interests.
Funding
The study was sponsored by Novartis.
Author Contributions
SY: Literature search, figures, study design, data collection, data analysis, data interpretation and writing/reviewing the manuscript; HD: Data collection, data interpretation and writing/reviewing the manuscript; IS: Data collection, data interpretation and writing/reviewing the manuscript; YMS: Literature search, data collection, data interpretation and writing/reviewing the manuscript; YSS: Literature search, figures, study design, data collection, data analysis, data interpretation and writing/reviewing the manuscript; NFA: Literature search, data interpretation and writing/reviewing the manuscript; SS: Data interpretation and writing/reviewing the manuscript; AS: Data collection, data interpretation, and writing/reviewing manuscript; PFY: Data collection, data interpretation, and writing/reviewing manuscript; JR: Data collection, data interpretation, and writing/reviewing manuscript; KHY: Data interpretation, and writing/reviewing manuscript; CH: Data interpretation, and writing/reviewing manuscript; HYL: Data interpretation, and writing/reviewing manuscript; VB: Data collection, data interpretation, and writing/reviewing manuscript; GA: Data collection, data interpretation, and writing/reviewing manuscript; LYB: Data collection, data interpretation, and writing/reviewing manuscript; HR: Data collection, data interpretation, and writing/reviewing manuscript; TJC: Data interpretation, and writing/reviewing manuscript; ML: Literature search, figures, data analysis, data interpretation, and writing/reviewing manuscript; CS: Study design, data collection, data analysis, data interpretation, and writing/reviewing manuscript; TLH: Literature search, figures, study design, data collection, data analysis, data interpretation, and writing/reviewing manuscript.
Acknowledgement
We thank the patients, caregivers, and investigators for their participation in the study. We also thank the worldwide network of research nurses, trial coordinators, and operations staff for their contributions. In addition, we would like to thank Ashwini Maratha, PhD, Anuradha Bandaru, PhD, of Novartis Healthcare Pvt. Ltd. for providing medical and editorial assistance with this manuscript.