Changes in lymphoproliferation parameters. (A) Individual and mean untransformed SPD of index lymph nodes. n values for all time points are 6. Reference range (≤1.5 × 1.5 cm) not shown because up to 6 lymph nodes may be counted per patient.²⁷ (B) Individual and mean liver volumes. n values for all time points are 6. (C) Individual and mean spleen volumes. n values for all time points are 6. Gray box indicates the reference range for adults.²⁸ Imaging used to determine lymphoproliferation for each patient at their first OLE readout was completed around year 1 (either ED168 or 252) of the OLE study. (D-F) Representative radiographic renderings of spleen volume from P6 at (D) screen of DFT (SCR), (E) end of the DFT (D84), and (F) first extension study readout (ED168) in which splenomegaly was absent. P6 had a 2-month gap in treatment between the end of part 1 and entry into the extension. D, day; ED, extension day; SCR, screen.