Sites may be rinsed with water, but soap and other possible irritants should be avoided. In the case of discomfort at the vaccination site, cold packs may be administered as needed. All other local treatments should only be administered after consultation with the investigator. 5.5 Dose Modification Guidelines and Toxicity Management A safety review team, internal to the sponsor, will regularly monitor all aspects of patient safety throughout this study. This team will be comprised of the medical m onitor, a statistician, and ad hoc authorized representatives as appropriate. The safety review team will meet regularly to review all SAEs and will examine non -serious AEs, clinical laboratory data and other relevant safety data. 5.5.1 Local Reactions Local reactions, resulting from the vaccine will be graded using the local reaction assessment scale (Table 2). Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 44 of 81 CONFIDENTIAL Table 2. Local Reaction Assessment Scale Grade Description 0 = None Not Applicable.