Dose Adjustment S ee the Dose Reductions section of the protocol. 4.General Statistical Considerations C ontinuous data will be described using descriptive statistics as follows: number of observations (n), mean, median, standard deviation, minimum, and maximum. All minimum and maximum values will be displayed with the same number of decimal places relative to the raw data, the mean and median will be displayed with one additional decimal place, and the standard deviation will be displayed with two additional decimal places. Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 5 Revised: June 2015 Data listings will be displayed by subject identification number. Summary tables will be displayed by treatment arm for all subjects. For those summary tables in which baseline and change from baseline measurements will be presented, if time is not available the last observed measurement on or before the date of initial dose of study product will be considered the baseline measurement. If date and time are available the last observed measurement on or before the date and time of initial dose of study product will be considered the baseline measurement. S tudy Day 1 is defined as the date of first dose of study product. For visits (or events) that occur on or after the first dose of study product, study day is defined as visit date (event date) – date of first dose of study product + 1. For visits (or events) that occur before the first dose of study product, study day is defined as visit date (event date) – date of first dose of study product. There is no Study Day 0. F or listings that include the derivation of “days since last dose,” this is defined as event date – date of last dose. Events that occur on the same day as the last dose of stu dy product will therefore be described as occurring zero days from the last dose of study product. W hen categorical data are presented, the percentage will be suppressed when the count is zero in order to draw attention to the non-zero counts. The denomi nator for all percentages , unless otherwise specified, will be the number of subject s in each treatment arm or overall. O nly nominal/scheduled visit data will be reported in the tables. All visits, including unscheduled visits, will be presented in the l istings. Note that all scheduled visits should occur within ± 3 days of the protocol- specified visit schedule. 4.1.