Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 26 Revised: June 2015 14.Appendix A: Delayed Effect Simulation Methodology T he trial size and interim analyses w ere planned using clinical trials simulation software developed by Brent A. Blumenstein, PhD, the statistical consultant providing the statistical design of this study.