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Exploratory Biomarker Data

Descriptive statistics will be performed to summarize the exploratory biomarker data.

The descriptive statistics include, N/Means/Median/Std Dev/Range (min-max) for the Vectra biomarker testing data (e.g., Vectra-DA [disease activity] score), change or percent change from baseline across sample collection time points for each treatment group.

Correlations between hs-CRP and Vectra CRP may be calculated.

9. SUBGROUP ANALYSIS

Subgroup analyses will be performed to support regional regulatory submissions. These analyses include Japan and other regions.

Patient subgroups in this study will include baseline parameter such as age category (=65 years), gender (male, female), race (white, black, Asian), region (North America and Western Europe, Japan, South Korea, Latin America and Rest of the World), corticosteroid use (y/n) and duration of prior MTX (