1. Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
2. Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA
3. Medical Device Innovation Consortium, Minneapolis, MN, USA
4. Department of Epidemiology, Janssen Research & Development, Titusville, NJ, USA