Viral Tests : Hepatitis B (HepB), hepatitis C (HepC), or human immunodeficiency virus (HIV) infection . 5.2.3 Vital Signs Vital Signs include body temperature, heart rate, respiratory rate, and resting systol ic and diastolic blood pressure . On the day of each dosing, vital signs will be obtained before dosing and 30 minutes after dosing (±10 minute window). Blood pressure and heart rate will be measured no more than 60 minutes before the scheduled dosing. 5.2.4 Electrocardiogram (ECG) ECG includes heart rate, PR interval, R R interval , QRS duration, QT interval, QTc interval and overall i nterpretation. 5.2.5 Other Safety Endpoints ECOG, physical examination by body system , dosing and extent of exposure , prior and concomitant medication, and LV305 persistence will be also included to evaluate the safety of study treatment. 6 ANALYSIS S ETS Three analysis sets are considered in the st atistical analysis of the study : Intent -to-Treat set (ITT), Efficacy Eva luable set (EE), and Safety set . 05FPRF Immune Design Corp. I MDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 23 / 36 6.1 ITT Set The ITT set consists of all subjects randomized. All analyses of this set will be based on the randomized treatment arm to which the subjects are assigned. Efficacy analyses performed in the ITT set will be considered to be the primary indicator of efficacy . 6.2 EE Set The EE set consists of all subjects without major protocol violations, who have received at least 1 dose of study treatment , and have the baseline and at least 1 post -baseline tumor assessments available. The EE se t will be analyzed according to the treatment received. Efficacy analyses performed in the EE set will be considered to be supportive. 6.3 Safety Set The Safety set consists of all subjects taking any amount of study drug. The s afety set is the primary set for safety analyses including AEs and clinical laboratory data. Study treatment exposure also will be summarized using the s afety set. 7 GENERAL STATISTICAL CONSIDERATIONS 7.1 Data Summaries and Conventions Formal statistical tests will be performed for inference , unless otherwise specified , P-values will be reported to four (4) decimal places and those less than 0.0001 will be reported as <0.0001, 2 - side 95% confidence intervals will be presented where appropriate. A ll analyses will be presented by treatment arm and overall.