| Description | Date | Size |
|---|
| Overview and Control Document - Version History and Notice of Changes (Download) | 2020-01-13 | 1.04 MB |
| Table of Contents - Current Sections (Download) | 2020-01-13 | 61.86 KB |
| Section 01: Introduction (Download) | 2020-01-13 | 185.83 KB |
| Section 02: Documentation Requirements (Download) | 2019-07-01 | 211.73 KB |
| Section 03: Participant Accrual and Retention (Download) | 2020-01-13 | 209.46 KB |
| Section 04: Informed Assent and Consent (Download) | 2019-07-01 | 318.43 KB |
| Section 05: Study Procedures (Download) | 2020-01-13 | 383.62 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2020-01-13 | 411.92 KB |
| Section 07: Clinical Considerations (Download) | 2020-01-13 | 376.59 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2020-01-13 | 493.35 KB |
| Section 09: Laboratory Considerations (Download) | 2020-01-13 | 873.15 KB |
| Section 10: Counseling Procedures (Download) | 2020-01-13 | 333.65 KB |
| Section 11: Behavioral Assessments (Download) | 2020-01-13 | 814.15 KB |
| Section 12: Data Collection (Download) | 2020-01-13 | 525.64 KB |
| Section 13: Data Communiqués (Download) | 2019-01-04 | 132.51 KB |
| Section 13: Data Communiqué #1 (Download) | 2018-11-01 | 103.64 KB |
| Section 13: Data Communiqué #2 (Download) | 2019-03-13 | 115.04 KB |
| Section 13: Data Communiqué #3 (Download) | 2019-05-23 | 159.57 KB |
| Section 13: Data Communiqué #4 (Download) | 2019-11-12 | 125.68 KB |
| Section 14: Study Reporting Plan (Download) | 2020-01-13 | 225.29 KB |