2 CHANGES TO THE FINAL SAP 2.1 Immune Res ponse These changes relate to section 6.1 of the final SAP. In addition to the reporting detailed in section 6.1 of the SAP, a summary table will present the number and percentage of patients in the categories below: - Patients with an initial immune respons e by Week 11 or 12 (main group) or by Week 13 (concomitant group) or by Week 8 (modified vaccination group). - Patients with an immune response during chemotherapy based on dates of chemotherapy treatment per patient (this will include immune assessments taken approximately 8 weeks after end of chemotherapy). - Patients with an immune response post chemotherapy to week 50 (this will include immune response for end of study samples taken in the period after immune assessment taken approximately 8 weeks after end of chemotherapy and within week 50, by actual study dates). - Patients with an immune response at week 52 (this includes week 51 – 53 by actual study dates). - Patients with an immune response at the end of the study i.e. immune response after week 53, by actual study dates. - Patients with at least one immune response over the entire study course. Patients who discontinued from the study before the specific period will be classed as “Not applicable” and patients for which samples were not taken w here they should have been will be classed as “Missing”. This table will be presented for both the MIAS and IAS population.