Individual Sections| Overview of Section Contents (Download) | 2015-11-16 | 187.67 KB |
| Section 01: Introduction (Download) | 2015-06-24 | 220.15 KB |
| Section 02: Documentation Requirements (Download) | 2015-06-24 | 318.4 KB |
| Section 03: Accrual and Retention (Download) | 2015-06-24 | 238.08 KB |
| Section 04: Study Procedures (Download) | 2015-08-18 | 356.32 KB |
| Section 05: Informed Consent (Download) | 2015-06-24 | 296.96 KB |
| Section 06: Web Randomization (Download) | 2015-10-12 | 766.31 KB |
| Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) | 2015-06-24 | 519.15 KB |
| Section 08: Clinical Considerations and Safety Monitoring (Download) | 2015-09-01 | 708.32 KB |
| Section 09: Laboratory Considerations (Download) | 2015-08-18 | 713.09 KB |
| Section 10: Counseling Considerations (Download) | 2015-06-24 | 164.35 KB |
| Section 11: Data Collection (Download) | 2015-08-18 | 960.69 KB |
| Section 12: Data Communiqués (Download) | 2015-06-24 | 98.36 KB |
| Section 12: Data Communiqué #1 (Download) | 2015-09-02 | 204.19 KB |
| Section 13: Study Reporting Plan (Download) | 2015-11-16 | 428.26 KB |
