Table 2.
Schedule of activities.
| Procedures | Preenrollment | Enrollment, day 0 | Day 1-30 | Day 31-60 | Day 61-90 | Day 91-120 | Day 121-150 | Day 151-180 |
| Screening | ✓ |
|
|
|
|
|
|
|
| Informed consent |
|
✓ |
|
|
|
|
|
|
| Eligibility verification |
|
✓ |
|
|
|
|
|
|
| Baseline questionnaire |
|
✓ |
|
|
|
|
|
|
| Physiological data collection (number of days) |
|
|
30✓ | 8✓ | 8✓ | 8✓ | 8✓ | 8✓ |
| Ecological momentary assessments (number of EMAsa) |
|
|
30✓ | 4✓ | 4✓ | 4✓ | 4✓ | 4✓ |
| Monthly survey (number of surveys) |
|
|
1✓ | 1✓ | 1✓ | 1✓ | 1✓ | 1✓ |
| Adverse outcomes survey (as applicable) |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Technical or general support (patient-initiated) |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
aEMA: ecological momentary assessment.