| Description | Date | Size |
|---|
| Overview and Control Document - Version History and Notice of Changes (Download) | 2021-01-05 | 1.12 MB |
| Table of Contents - Current Sections (Download) | 2021-01-05 | 62.14 KB |
| Section 01: Introduction (Download) | 2020-07-22 | 185.95 KB |
| Section 02: Documentation Requirements (Download) | 2020-07-22 | 215.99 KB |
| Section 03: Participant Accrual and Retention (Download) | 2020-07-22 | 207.6 KB |
| Section 04: Informed Assent and Consent (Download) | 2019-07-01 | 318.43 KB |
| Section 05: Study Procedures (Download) | 2020-07-22 | 380.46 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2021-01-05 | 407.28 KB |
| Section 07: Clinical Considerations (Download) | 2021-01-05 | 392.38 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2021-01-05 | 493.87 KB |
| Section 09: Laboratory Considerations (Download) | 2021-01-05 | 863.97 KB |
| Section 10: Counseling Procedures (Download) | 2021-01-05 | 313.97 KB |
| Section 11: Behavioral Assessments (Download) | 2021-01-05 | 812.12 KB |
| Section 12: Data Collection (Download) | 2021-01-05 | 525.37 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 13: Data Communiqué #5 (Download) | 2020-02-14 | 40.8 KB |
| Section 13: Data Communiqué #6 (Download) | 2020-03-27 | 35.98 KB |
| Section 13: Data Communiqué #7 (Download) | 2020-07-22 | 121.94 KB |
| Section 14: Study Reporting Plan (Download) | 2020-07-22 | 229.11 KB |