1. a Federal Institute for Drugs and Medical Devices , Bonn, Germany
2. b Medical University of Vienna , Vienna, Austria
3. c Statistical Methodology , Novartis Pharma AG , Basel, Switzerland
4. d Hoffmann-La Roche , Basel, Switzerland
5. e University Medical Center Göttingen , Göttingen, Germany
6. f U.S. Food and Drug Administration , Silver Spring, Maryland, USA