Individual Sections| Overview of Section Contents (Download) | 2015-04-22 | 195.24 KB |
| Table of Contents (Download) | 2015-03-11 | 27.42 KB |
| Section 01: Introduction (Download) | 2015-03-11 | 145.79 KB |
| Section 02: Documentation Requirements (Download) | 2015-03-11 | 69.49 KB |
| Section 03: Participant Accrual and Retention (Download) | 2015-03-11 | 366.07 KB |
| Section 04: Informed Consent (Download) | 2015-03-11 | 491.29 KB |
| Section 05: Study Procedures (Download) | 2015-04-22 | 489.32 KB |
| Section 06: Counseling and Behavioral Considerations (Download) | 2015-03-11 | 170.63 KB |
| Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) | 2015-03-11 | 1.32 MB |
| Section 08: Clinical Considerations (Download) | 2015-03-11 | 541 KB |
| Section 09: Adverse Event Reporting and Safety Monitoring (Download) | 2015-03-11 | 444.14 KB |
| Section 10: Laboratory Considerations (Download) | 2014-10-02 | 575.31 KB |
| Section 11: Data Collection (Download) | 2015-03-11 | 570.99 KB |
| Section 12: Data Communiques (Download) | 2013-04-22 | 10.54 KB |
| Section 12: Data Communiques #1 (Download) | 2013-08-12 | 65.9 KB |
| Section 12: Data Communiques #2 (Download) | 2013-11-05 | 55.33 KB |
| Section 12: Data Communiques #3 (Download) | 2014-02-21 | 25.16 KB |
| Section 12: Data Communiques #4 (Download) | 2014-04-18 | 31.73 KB |
| Section 12: Data Communiques #5 (Download) | 2014-05-12 | 29.28 KB |
| Section 12: Data Communiques #6 (Download) | 2014-08-07 | 155.68 KB |
| Section 12: Data Communiques #7 (Download) | 2015-02-17 | 26.42 KB |
| Section 13: Study Reporting Plan (Download) | 2015-03-11 | 169.19 KB |
