| Authors: |
Storm NE; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. nstorm@amgen.com.; Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California (USC), 1540 Alcazar Street, CHP 140, Los Angeles, CA, 90089-9014, USA. nstorm@amgen.com., Kubik C; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Priem G; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Kim M; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Lin TC; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Lange J; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., O'Connell C; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Glennane A; Global Development, General Medicine, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Bradbury BD; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Taisey MJ; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. |