I. Individual Sections - Version 2| Overview of Section Contents (Download) | 2013-11-13 | 41.59 KB |
| Section 01: Introduction (Download) | 2013-11-13 | 131.51 KB |
| Section 02: Protocol (Download) | 2013-11-13 | 33.78 KB |
| Section 03: Documentation Requirements (Download) | 2013-11-13 | 283 KB |
| Section 04: Participant Accrual and Enrollment (Download) | 2013-11-13 | 587.71 KB |
| Section 05: Participant Follow-up (Download) | 2013-11-13 | 292.76 KB |
| Section 06: Participant Retention (Download) | 2013-11-13 | 215.91 KB |
| Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) | 2013-11-13 | 509.37 KB |
| Section 08: Clinical Considerations and Safety Monitoring (Download) | 2013-11-13 | 402.26 KB |
| Section 09: Laboratory Considerations (Download) | 2013-11-13 | 916.25 KB |
| Section 10: Data Collection (Download) | 2013-11-13 | 2.27 MB |
| Section 11: Data Communiqués (Download) | 2013-11-13 | 307.19 KB |
| Section 12: Behavioral Measures (Download) | 2013-11-13 | 923.79 KB |
| Section 13: Counseling Considerations (Download) | 2013-11-13 | 560.19 KB |
| Section 14: Study Reporting Plan (Download) | 2013-11-13 | 88.79 KB |
II. Individual Sections - Version 1| Overview of Section Contents (Download) | 2013-09-03 | 76.14 KB |
| Section 01: Introduction (Download) | 2012-09-24 | 131.77 KB |
| Section 02: Protocol (Download) | 2012-09-24 | 33.12 KB |
| Section 03: Documentation Requirements (Download) | 2012-09-24 | 283.27 KB |
| Section 04: Participant Accrual and Enrollment (Download) | 2013-08-08 | 588.21 KB |
| Section 05: Participant Follow-up (Download) | 2013-08-08 | 257.38 KB |
| Section 06: Participant Retention (Download) | 2012-09-24 | 213.44 KB |
| Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) | 2012-09-24 | 516.62 KB |
| Section 08: Clinical Considerations and Safety Monitoring (Download) | 2013-08-08 | 401.37 KB |
| Section 09: Laboratory Considerations (Download) | 2013-09-03 | 1.32 MB |
| Section 10: Data Collection (Download) | 2012-11-06 | 1.5 MB |
| Section 11: Data Communiques (Download) | 2012-09-24 | 28.95 KB |
| Section 11: Data Communiques #1 (Download) | 2012-10-02 | 101.94 KB |
| Section 11: Data Communiques #2 (Download) | 2012-10-31 | 322.6 KB |
| Section 11: Data Communiques #3 (Download) | 2013-02-14 | 223.11 KB |
| Section 12: Behavioral Measures (Download) | 2013-02-21 | 784.65 KB |
| Section 13: Counseling Considerations (Download) | 2012-09-24 | 524.01 KB |
| Section 14: Study Reporting Plan (Download) | 2012-09-24 | 47.62 KB |
