| Description | Date | Size |
|---|
| 01: Study Overview (Download) | 2015-06-12 | 486.17 KB |
| 02: Screening Visit Procedures (Download) | 2015-06-12 | 1.81 MB |
| 03: Enrollment Visit Procedures (Download) | 2015-06-12 | 1.14 MB |
| 04: Randomization and Participant Replacement (Download) | 2015-06-12 | 1.02 MB |
| 05: Study Product Considerations (Download) | 2015-06-12 | 906.18 KB |
| 06: Follow-up Visit Procedures (Download) | 2015-06-12 | 1.52 MB |
| 07: Laboratory Considerations (Download) | 2015-06-12 | 2.37 MB |
| 09: Laboratory Related CRFs (Download) | 2015-06-12 | 595.27 KB |
| 01: Clinical Considerations (Download) | 2015-06-12 | 1.52 MB |
| 02: AE/SAE/EAE Identification and Reporting (Download) | 2015-06-12 | 218.72 KB |
| 03: Clinical Management CRFs (Download) | 2015-06-12 | 375.61 KB |
| 04: Training Scenarios Answer Key (Download) | 2015-06-12 | 365.19 KB |