Full details of the protocol will be in the Study Manual. Laboratory Evaluations 5.1.1 Specimen Collection, Preparation, Handling and Shipping Biomarker samples (Full details are provided in the separate Biomarkers Technical Manual) 1. Collect 3, 10 ml tubes each of serum and K3 EDTA plasma in the fasting state (or indicated non-fasting if fasting samples cannot be obtained) DNA samples