These will require the approval of all signatories of the final protocol. Any amendments to the protocol which affect the patient, e.g. changes in procedures/assessments or matters relating to patient safety, require a favourable opinion approval from the Ethics Committee for the trial centre(s) concerned, prior to implementation. Changes of a purely administrative nature should be notified to the committee(s), but do not require formal approval. Any amendment affecting the patient requires further informed consent from each patient before implementation. CT TG01 -01 Version v 10.0 27 June 2018 Confidential 80 / 87 9.5 Deviations from the trial protocol Deviations from the trial protocol, especially the prescription of doses not scheduled in the trial protocol, other modes of administration, other indications, and longer treatment periods are not permissible (except in an emergency). 9.6 Trial report and publication policy After the conclusion of the trial, a report will be written with the co -operation of the Investigators and in conjunction with Targovax, which will include a descriptive statistical analysis and an appraisal of the results from a medical viewpoint. This report will be based on the items listed in this trial protocol. Any publication of the results, either in part or in total (articles in journals or newspapers, oral presentation, etc.) by the Investigators, requires the approval of Targovax . 9.7 Volume of blood sampling and handling of biological samples The total volume of blood that will be drawn from each patient in this trial will vary depending on how long the patient stays on study. Table 6: Volume of blood to be drawn from each patient in the study Assessment Sam ple volume (ml) No. of samples Total volume (ml) Immunology 60 5 300 CA19.9 5 9 45 Other analysis 10 9 90 Safety Clinical chemistry 5 23-31 115-155 Haematology 5 23-31 115-155 Total 665-745 ml CT TG01 -01 Version v 10.0 27 June 2018 Confidential 81 / 87 10. REFERENCES 1.