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US FDA, Lab Immunol & Dev Biol, Div Cellular & Gene Therapies, Off Cellular Tissue & Gene Therapies,Ctr Biol Eva, Rockville, MD 20857 USA US FDA, Lab Immunol & Dev Biol, Div Cellular & Gene Therapies, Off Cellular Tissue & Gene Therapies,Ctr Biol Eva, Rockville, MD 20857 USA