Table 3.
Milestones for Years 2–5
| Milestones by Year | Y2 | Y3 | Y4 | Y5 |
|---|---|---|---|---|
| Meet with the Data and Safety Monitoring Board annually | X | X | X | X |
| Meet with the Advisory Board regularly (every 6 months) to assess study protocol implementation performance | X | X | X | X |
| Meet with the Executive Committee regularly (every 4 months) to assess study protocol implementation performance | X | X | X | X |
| Prepare and submit annual review for NHLBI | X | X | X | X |
| Completion of 40% of projected enrollment | X | |||
| Completion of 70% of projected enrollment | X | |||
| Completion of 100% of projected enrollment | X | |||
| Prepare baseline manuscript | X | |||
| Publish baseline manuscript | X | |||
| Total patients randomized N =150 | X | |||
| Lock the database | X | |||
| Analyze data and prepare results manuscript | X | |||
| Plan to disseminate results and submit to clinicaltrial.gov within 12 months of primary completion date | X |