Data Supplement

Eight tables; one Word document.

Files in this Data Supplement:

• E1 - Table (E)T-1: Secondary outcomes of efficacy; Table (E)T-2: Tertiary outcomes influenced by treatment; Table (E)T-3: Adverse events associated with treatment and occurring in 5% or more of total study population; Table (E)T-4: Lymphopenia and liver function abnormalities; Table (E)T-5: Results of blinding survey at week 156; Table (E)T-6: Tertiary outcome measures; Table (E)T-7: Statistical plans; Table (E)T-8: Tertiary outcomes; one Word document.