4 of t he C S P). T he met h o d ol o g y descri be d i n t his S A P f or t he deri vat i o n of visit res p o nses a n d efficac y v aria bles will als o be use d f or t he D R C a nal yses. F urt her i nf or mati o n ar o u n d t he a nal ysis a n d o ut p uts re q uire d t o facilitate t his will be descri be d i n t he D R C c harter. 6 C H A N G E S O F A N A L Y SI S F R O M P R O T O C O L As t here is n o c urre nt pla n t o i nc or p orate ir R E CI S T, t his has n ot bee n refere nce d i n t he S A P. T he defi nit i o n of t he e val u a ble f or res p o nse a nal ysis set has bee n u p date d t o ali g n wit h t he defi nit i o n i n t he D R C c harter . A n a d dit i o n al se nsi ti vi t y a nal ysis of O R R usi n g u nc o nfir me d res p o nses has bee n a d de d. Cl arificat i o n has bee n a d de d t hat t he mi d -P m et h o d ol o g y i s a p plica ble o nl y if t he c o h orts are e x pa n de d. Vi si t wi n d o wi n g of safet y d o m ai ns will be c o nsi dere d u p t o e n d of treat me nt, rat her t ha n u p t o pr o gressi o n as me nt i o ne d i n t he pr ot oc ol. A n a d dit i o n al efficac y list i n g detaili n g d ose -fi n di n g c o h ort o verall R E CI S T res p o nse per i n vesti gat or assess me nt has bee n a d de d. C CI C CI Statistical Analysis Plan Study Code D419EC00001 Edition Number 4.0 Date 19Apr2023 CONFIDENTIAL AND PROPRIETARY 65of 657 REFERENCES Porcher and Desseaux 2012 Porcher R, Desseaux K. What inference for two -stage phase II trials? BMC Med Res Methodol .