, reduced dose or modified number of vaccinations) are not expected but would be considered by the Sponsor an d Chief Investigator based on vaccine availability or if plateaued immune responses were observed with fewer vaccinations in those patients already treated . SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 17 5.7 Adverse Events Pre-treatment AEs will be defined as those where “Did this AE start prior to first vaccination ?” is ticked. Treatment Emergent AEs (TEAEs) will be defined as those where “Did this AE start prior to first vaccination ?” is not ticked. Related AEs are those where causality to IMP is considered to be Possible, Probable or Highly Probable. The frequency of adverse events will be summarised overall . A patient can be counted multiple times per row for the No. of Episodes but will only be counted once per row for the No.