In the event of future amendments to the protocol, this statistical analysis plan (SAP) may be modified to account for changes relevant to the statistical analy sis. The table, listing and figure shells (TFLs) will be supplied in a separate document but form part of the complete SAP document. 2 GENERAL PRINCIPLES The analysis and statistics reporting will be conducted at Syne qua non using SAS version 9.2 or higher . All listings will be based on all treated patient s unless specified otherwise. Listings and figures will be presented by Main group, Concomitant group and Modified vaccination group. Tables will be presented by Main group, Concomitant group, Main + Concomitant, Modified vaccination group separately unless otherwise specified and Overall (Main + Concomitant + Modified vaccination) . Descriptive summary statistics for continuous variables will include the number of patient s (n), mean, standard deviation (SD), median, interquartile range, minimum and maximum unless specified otherwise. The precision of these summary statistics is defined in the TFL shells document. Descriptive summary statistics for categorical variables will include frequency counts and percentages [ n (%)]. In general, the denominator for percentage calculations will be the number of patient s in the analysis set.