3. 4, re m o ve d t he vital si g ns s hift ta ble . Secti o n 6, u p date d t o i ncl u de a n y rele va nt c ha n ge detaile d a b o ve. C CI Statistical A nal ysis Pla n St u d y C o de D 4 1 9 E C 0 0 0 0 1 E diti o n N u m ber 4. 0 Date 1 9 A pr 2 0 2 3 C O N FI D E N TI A L A N D P R O P RI E T A R Y 9of 6 5 D ate Brief descri pti o n of c h a n ge 1 7 N o v 2 0 2 2 Re m o ve d si g nat ure pa ges. Secti o n 2. 1, m ore clarificati o n pr o vi de d f or E val ua ble f or res p o nse a nal ysis set, a n d o nl y deri ve f or D ose e x pa nsi o n p hase . Secti o n 3.