6.3. Eligibility E ligibility deviations consist of any violations of the inclusion and exclusion criteria as detailed in the protocol. Eligibility deviations and other protocol deviations captured in the CTMS will be presented in separate listings. 7.Treatm ents and Medications 7.1. Prior and Concomitant Medications and Non- Drug Therapies A ll medications recorded on the eCRF will be coded using the World Health Organization (WHO) Drug Dictionary. Prior and concomitant medications will be summarized for the FAS by Anatomical -Therapeutic- Chemical (ATC) Class Level 4 and WHO Drug Substance preferred term (PT). Subjects may have more than one medication per drug class and preferred term. At each level of summarization, a subject is counted once if he/she reported one or more medications at that level. P rior medications are defined as medications with a stop date occurring before the date of first dose. Concomitant medications are defined as medications with start dates occurring on or after date of first dose and before the date of last dose + 28 days. Any medication with start and stop dates that bracket the date of first dose will be summarized as both prior and concomitant medications. Medications with start dates occurring more than 28 days after the date of last dose will be defined as Follow -up medications. F or the purpose of inclusion in prior and/or concomitant medication tables, incomplete medication start and stop dates will be imputed as detailed in Appendix C of this document. Based on imputed start and stop dates, medications that clearly stopped before date of first dose Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 11 Revised: June 2015 will be included in the prior medications table, and medications that clearly started on or after date of first dose and before t he date of last dose + 28 days will be included in the concomitant medications table. All other medications will be included in both the prior and concomitant medications tables. P rior and concomitant medications will be presented in a listing. Follow-up medications will be presented in a separate listing.