Author information: (1)Data First Consulting, Sebastopol, California, USA. (2)Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. (3)Vitalant Research Institute, San Francisco, California, USA. (4)Edward Grebe Consulting, Cape Town, South Africa. (5)ViiV Healthcare, Research Triangle Park, North Carolina, USA. (6)Gilead Sciences, Foster City, California, USA. (7)University of Washington, Seattle, Washington, USA. (8)Independent Consultant, Washington, DC, USA. (9)Merck & Co., Inc., Kenilworth, New Jersey, USA. (10)Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany. (11)Forum for Collaborative Research, Washington, DC, USA.