7. 2 will be liste d b y pat ie nt . will be re p orte d i n t he C S R. S u m maries a n d a nal yses f or e x pl orat or y bi o m ar kers will be d oc u me nte d i n a se parate a nal ysis pl a n a n d will be re p orte d o utsi de t he C S R i n a se parate re p ort. Base d o n a vaila bilit y of data, a d dit i o nal e x pl orat or y bi o m ar ker a nal yses m a y be perf or m e d. 5 I N T E RI M A N A L Y S E S N o f or m al i nt eri m a nal ysis f or efficac y i s pla n ne d f or t hi s st u d y . H o we ver, i n d ose -e x pa nsi o n p hase, O R R will be e val uate d o n a n o n g oi n g basis f or t he first 1 1 e val ua ble pat ie nt s ( S A R C O M A c o h ort) t o c o m plete Sta ge 1 of t he Si m o n 2 -Sta ge o pti mal desi g n (see Sect i o n 4. 1.