12 CONSIDERATIONS FOR DATA ANALYSIS .............................................................. 13 Programming Environment ....................................................................................... 13 Statistical Notation and Methodology ........................................................................ 13 DATA HANDLING METHOD S ..................................................................................... 13 Missing Data ............................................................................................................. 13 10.1.1 Date V alues ....................................................................................................... 13 10.1.2 Non-Date Values ............................................................................................... 14 Visit Windows ............................................................................................................ 14 Data Derivations and Definitions ............................................................................... 14 STUDY POPULATION ................................................................................................. 15 Subject Disposition ................................................................................................... 15 Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 3 of 19 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document.