1. Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
2. Biostatistics and Research Decision Sciences, Merck & Co., Inc, Kenilworth, NJ
3. Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
4. Bayer, Montreal, Canada
5. Product Development Data Sciences, F. Hoffmann-La Roche, Basel, Switzerland
6. Analytics, Novartis Pharma AG, Basel, Switzerland
7. Section for Medical Statistics, Medical University of Vienna, Vienna, Austria