Individual Sections| Overview of Section Contents (Download) | 2015-11-04 | 129.89 KB |
| Section 01: Introduction (Download) | 2015-05-15 | 222.86 KB |
| Section 02: Documentation Requirements (Download) | 2015-09-15 | 322.3 KB |
| Section 03: Accrual and Retention (Download) | 2015-05-15 | 318.64 KB |
| Section 04: Study Procedures (Download) | 2015-05-15 | 372.31 KB |
| Section 05: Informed Consent (Download) | 2015-05-15 | 349.08 KB |
| Section 06: Web Randomization (Download) | 2015-11-04 | 753.89 KB |
| Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) | 2015-05-15 | 525.87 KB |
| Section 08: Clinical Considerations and Safety Monitoring (Download) | 2015-09-15 | 671.29 KB |
| Section 09: Laboratory Considerations (Download) | 2015-09-15 | 1011.63 KB |
| Section 10: Counseling Considerations (Download) | 2015-05-15 | 265.62 KB |
| Section 11: Behavioral Measures (Download) | 2015-09-23 | 422.4 KB |
| Section 12: Data Collection (Download) | 2015-05-15 | 888.3 KB |
| Section 13: Data Communiqués (Download) | 2015-05-15 | 98.56 KB |
| Section 13: Data Communiqué #1 (Download) | 2015-06-15 | 134.88 KB |
| Section 13: Data Communiqué #2 (Download) | 2015-09-15 | 135.58 KB |
| Section 14: Study Reporting Plan (Download) | 2015-11-04 | 277.18 KB |
