Individual Sections| Table of Contents - Current Sections (Download) | 2018-06-28 | 68.06 KB |
| Overview and Control Document - Version History and Summary of Changes (Download) | 2018-06-28 | 796.66 KB |
| Section 01: Introduction (Download) | 2018-06-28 | 225.31 KB |
| Section 02: Decliner Population (Download) | 2018-06-28 | 408.63 KB |
| Section 03: Documentation Requirements (Download) | 2018-06-28 | 363.34 KB |
| Section 04: Participant Accrual, Screening and Enrollment (Download) | 2018-06-28 | 442.92 KB |
| Section 05: Informed Consent (Download) | 2018-06-28 | 274.33 KB |
| Section 06: Participant Follow-up (Download) | 2018-06-28 | 583.13 KB |
| Section 07: Behavioral Assessments and ACASI User Manual (Download) | 2018-06-28 | 2.51 MB |
| Section 08: Participant Retention (Download) | 2018-06-28 | 297.56 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) | 2018-06-28 | 383.49 KB |
| Section 10: Clinical Considerations (Download) | 2018-06-28 | 491.67 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring (Download) | 2018-06-28 | 966.29 KB |
| Section 12: Counseling Considerations (Download) | 2018-06-28 | 1.01 MB |
| Section 13: Laboratory Considerations (Download) | 2018-06-28 | 1.53 MB |
| Section 14: Data Collection (Download) | 2018-06-28 | 1.12 MB |
| Section 15: Data Communiques (Download) | 2018-06-28 | 137.29 KB |
| Section 15: Data Communiqué #1 (Download) | 2016-09-19 | 112.84 KB |
| Section 15: Data Communiqué #2 (Download) | 2016-10-21 | 313.46 KB |
| Section 15: Data Communiqué #3 (Download) | 2016-11-23 | 30.99 KB |
| Section 15: Data Communiqué #4 (Download) | 2016-12-01 | 121.81 KB |
| Section 15: Data Communiqué #5 (Download) | 2017-04-14 | 29.74 KB |
| Section 15: Data Communiqué #6 (Download) | 2017-04-21 | 241.04 KB |
| Section 15: Data Communiqué #7 (Download) | 2017-07-31 | 36.33 KB |
| Section 15: Data Communiqué #8 (Download) | 2017-09-29 | 34.65 KB |
| Section 15: Data Communiqué #9 (Download) | 2018-01-17 | 25.83 KB |
| Section 15: Data Communiqué #10 (Download) | 2018-02-12 | 25.25 KB |
| Section 15: Data Communiqué #11 (Download) | 2018-04-12 | 43.29 KB |
| Section 15: Data Communiqué #12 (Download) | 2018-07-05 | 99.3 KB |
| Section 16: Study Reporting Plan (Download) | 2018-06-28 | 216.64 KB |
| Section 17: HOPE Qualitative Component (Download) | 2018-06-28 | 1.59 MB |
| Section 18: HOPE CHARISMA Component (Download) | 2018-06-28 | 209.5 KB |
