Do not make unauthorized copies. 10.1.2 Non-Date Values Every effort will be made to obtain the protocol -required data for all study assessments that are scheduled for each scheduled visit for all subjects who have been enrolled. The primary endpoint is progression free survival, survival models (Kaplan-M eier estimates and Cox model) which take into account censored observations will be used. There will be no imputation for missing data for the primary endpoint. Visit Windows Study visit periods will be windowed as applicable as shown in Section 6.0 . Values will be presented for all scheduled study visits according to the nominal visit obtained from the CRF. If an unscheduled visit falls in a visit window with an existing nominal visit assessment, the nominal assessment will be used for summary presentation. If no nominal visit assessment exists for a visit window with unscheduled visit(s), then the latest unscheduled visit within the visit window will be used. If multiple nominal assessments are collected within the same visit, the latest value and corresponding date will be used for summary presentation. All values will be included in the data listings. Data Derivations and Definitions The following definitions and derivations will be used for this study: Baseline for all assessments will be considered as the last non-missing assessment prior to the first administration of clinical trial material (CTM). Change from baseline will be calculated as: Change = observed value – baseline value. Study days on or after the initial dose of CTM will be computed as: Study Day = Date – Study Drug Start Date + 1. For pre-dosing dates, Study Day = Date – Study Drug Start Date. Age will be calculated from the date of birth to informed consent date. Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 15 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.