8.3.6 Dosing and Extent of Exposure Treatment exposure will be provided by treatment arm. The number of CMB305 or placebo injections, duration of exposure, and number of subjects with dose reductions/interruptions will be summarized by treatment arm based on the Safety set. Dosing and Extent of Exposure 05FPRF Immune Design Corp. I MDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 35 / 36 The duration of exposure is defined as the total number of days on the pl anned study treatment , temporary treatment discontinuation and planned treatment misses will be ignored. The following algorithm will be used to calculate the duration of study treatment exposure for subjects who took at least one dose of study treatment : Duration of exposure (days) = [(date of last administration of study treatment) – (date of first administration of study treatment) + 1] 8.3.7 Prior and Concomitant Medications All concomitant medications and prior medications will be coded to therapeutic d rug classes and generic drug names using the World Health Organization (WHO) Drug Classification. The incidence of prior and concomitant medication usage will be summarized by treatment arm, by therapeutic drug class, and generic drug names on safety set separately . Concomitant medication is any medication with start date on or after the initial dosing of study treatment. Prior medication is defined as any medication with start date on or before the first day of study treatment, or medication with start date missing . Each subject will be counted once only for each therapeutic drug class, generic drug names , and for the overall summary.