No imputation will be carried out on missing values. 9.4 Primary Endpoint The primary endpoint is the occurrence of at least 1 ≥Grade 4 local AE or 1 ≥Grade 3 systemic AE and/or signs/symptoms, lab toxicities, and/or clinical events that is probably or definitely related to study treatment (as judged by the safety review team, including site clinicians on the team) any time from Day 1 (Visit 2) until 21 days after administration of the vaccine (Visit 3). Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 64 of 81 CONFIDENTIAL 9.5 Statistical Analyses 9.5.1 Safety Analysis Major components for the safety analysis will include: • AEs solicited at every study visit, recorded, and coded according to the version of the Medical Dictionary for Regulatory Activities (MedDRA) that is current on the date of study initiation • SAEs • Vital signs and physical examination findings • Laboratory parameters All safety assessments will be summarized in a descriptive manner similar to the analysis described in Section 9.5.1.1. Data reported by the subjects in Patient Diary, including local signs related to the injection sites, physical fatigue, and body temperature , will be summarized in a descriptive manner.