9.2 Replacement of Subjects Any subject who withdraws from the study prematurely, or who discontinues study vaccination prematurely without experiencing a primary safety endpoint ( Section 9.4) before the Day 85 (Week 12, Vi sit 6) evaluation, and whose reasons for withdrawing from the study, or discontinuing study vaccination administration, are unrelated to any real or perceived effect of the study vaccination or its administration, will be replaced with another subject. If possible, all subjects who discontinue study treatment prematurely will be followed for 12 weeks for all study evaluations. A maximum of 5 subjects will be replaced without asking the sponsor ’s permission . If more than 5 subjects need to be replaced, then the study team may, for this reason, ask the sponsor for approval. 9.3 Handling of Missing, Unused, and Spurious Data 9.3.1 Missing Data Resulting from Study Withdrawal Only data collected from the visits by subjects will be included in the statistical analysis. No imputation will be carried out on missing values. 9.3.2 Intermediate Missing Data Only data collected from the visits by subjects will be included in the statistical analysis.