Therefore, it applies to deviations related to patient inclusion and clinical procedures (e.g. assessments to be conducted or parameters to be determined), and also to other procedures described in the protocol that concern the Good Clinical Practice (GCP) guidelines or ethical issues (e.g. issues related to obtaining the patients’ Informed Consent, data reporting, the responsibilities of the Investigator, etc.). Protocol deviations are captured throughout the trial open phase on the Sponsor’s central tracker and can be filtered by study and by deviation category or on the study specific pharmacokinetic/pharmacodynamic ( PK/PD ) deviations tracker (and the PK/PD tab [version 1] of the standard study tracker for deviations prior to set up of PK/PD deviations tracker) . Standard deviation categories have been defined by the Sponsor and are further defined by those which are deemed reportable (important deviations) in the CSR. Those deviations which have been coded as CSR reportable SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 15 will be summarised for all patients, according to the categories allocated at identification. Deviations are reviewed manually as per Sponsor standard operating procedures ( SOPs ). A summary ta ble with the number of patients with deviations will be presented per criterion. Deviations with no effects on the risk/benefit ratio of the clinical trial (such as minimal delays in assessments or visits) will be distinguished from those that might have a n effect on this risk/benefit ratio. The following are pre -defined protocol deviations with a direct bearing on the primary outcome and therefore will be reported in the CSR. A summary including but not necessarily restricted to the following categories w ill be presented: • Ineligible patients as per protocol. • Patient not withdrawn as per protocol. • Excluded concomitant medication. • Incorrect investigational medicinal product ( IMP) dose or schedule . Table 7: Protocol Deviations per C riterion Deviation criteria Number of Patients Patient Numbers Contraindicated medication Dosing error Eligibility criteria IMP (administration of expired/quarantined IMP) Missed visit or investigation PK/PD samples and endpoints Visit o r investigation conducted outside of window Imaging Other (serious breach/urgent safety measure not reported in required timelines) Deviations relating to all the other PD samples /endpoints will be documented in the individual PD reports and not in this summary table . 5.5 Treatment compliance Patients are expected to re ceive six AST-VAC2 vaccinations over a period of six weeks with an interval of 7 days (+/ -1 day) between each of the vaccination days . Dose reductions (i.e.