4.9.4 Withdrawal Patients may withdraw or be discontinued from the study as discussed in Section 4.6. Patients who do withdraw or are discontinued will be included in the efficacy analyses unless a patient withdraws consent to participate. In the instance of a patient withdrawing consent, any data collected will be excluded from analysis. 4.9.5 Missing data Every reasonable attempt will be made to recover any missing data. If any data for the primary efficacy measure remains missing that data point will be excluded from analysis for that patient. 4.9.6 Interim analysis No interim analysis is currently planned. 5.0 ADVERSE EVENTS Reporting of adverse events will be performed in accordance with the Data Safety Monitoring Plan (Appendix G) and Sections 5.2 and 5.3 below. 5.1 Adverse event and reporting definitions With the occurrence of an adverse event, the first concern will be for the safety of the patient. Investigators are required to report to the IRB, medical monitor, clinical research organization (CRO) Quality Assurance Officer or her designee and CRO Regulatory Affairs Officer any serious adverse event, whether expected or unexpected, and which is assessed by the investigator to be reasonably or possibly related to or caused by the vaccine components. Elective surgeries resulting in hospitalization and unrelated to the study agents will not be reported as SAEs, (breast reconstruction, etc.). All events meeting the outlined criteria will be reported for the time period beginning with any amount of exposure to vaccine components through the protocol-defined follow-up period.