7 1.2. Objectives of the Abbreviated Statistical Analysis Plan (ASAP) ............................................................................................. 7 2. STUDY OBJECTIVES ............................................................................... 8 2.1. Primary Objectives ......................................................................... 8 2.2. Secondary Objectives ...................................................................... 8 2.3. Exploratory Objectives ................................................................... 8 3. STUDY DESIGN ......................................................................................... 9 3.1. Synopsis of Study Design ......................................................... 9 3.2. Randomization and Blinding ................................................... 10 3.3. Study Procedures ...................................................................... 10 3.4. Study Endpoints ......................................................................... 10 3.4.1. Primary Endpoints ........................................................... 10 3.4.2. Secondary Endpoints ....................................................... 10 3.4.3. Exploratory Endpoints ..................................................... 11 4. SUBJECT POPULATIONS .................................................................... 12 4.1. Population Definitions .............................................................. 12 4.2. Protocol Deviations / Violations ............................................. 12 5. STATISTICAL METHODS ...................................................................... 13 5.1. Sample Size Justification ......................................................... 13 5.2. Statistical Methods .................................................................... 13 5.2.1. General Methods .............................................................. 13 5.2.2. Definitions ........................................................................ 14 5.2.3. Adjustments for Covariates .............................................. 15 5.2.4. Multiplicity ...................................................................... 15 5.2.5. Subgroup Analyses .......................................................... 15 Aduro Biotech, Inc. CONFIDENTIAL Protocol ADU -CL-02 Final Version 1 Page 4 of 24 04MAY2018 Section Page 5.2.6. Interim Analyses ................................