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The authors thank Drs. Karen Weiss, Keith Webber, Kathleen Clouse, Jay Lozier, and Andrew Chang for critical reading of the
Amy S. Rosenberg, M.D., is director of the Division of Therapeutic Proteins, CDER, FDA, Bldg 29A, Room 2D-16, 8800 Rockville Pike, Bethesda, MD 20892,
fax 301.480.3256, email@example.com
Alexandra S. Worobec, M.D., is a Medical Officer in the Division of Therapeutic Biological Oncology Products, CDER, FDA. Bldg. 10, Room 11C-208, 8800
Rockville Pike, Bethesda, MD 20892, firstname.lastname@example.org