Study oversight
The study was approved by independent ethics committees or institutional review boards at each site and was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines. All patients provided written informed consent. The study design and analyses were devised by the investigators and sponsor, and study data were collected by the investigators and their research teams. Final data analysis and verification of accuracy were conducted by Janssen. Investigators were not restricted by confidentiality agreements and had full access to all data. Writing assistance was funded by Janssen Global Services, LLC. The study was sponsored by Janssen Research & Development, LLC, and was registered at ClinicalTrials.gov (NCT03201965).