Data Supplement

Three figures, two tables, and one appendix; six Word documents.

Files in this Data Supplement:

• E1 - Figure 1; Word document.
• E2 - Figure 2; Word document.
• E3 - Figure 3; Word document.
• E4 - Table (E)T-1. Baseline characteristics; Word document.
• E5 - Table (E)T-2. No. of patients reporting AEs (total frequency >5%); Word document.
• E6 - Appendix; Word document.