Table 1 Data Collection Schedule
| Period | Screening | Run-in phase | Treatment period | Follow- up | ||
|---|---|---|---|---|---|---|
| Visit | 1st (D -7) | 2nd (D 1) | 3rd (D 29) | 4th (D 57) | 5th (D 71) | |
| Informed Consent | ○ | |||||
| Demographic Characteristics | ○ | |||||
| Medical History | ○ | |||||
| Safety Assessment | ○ | ○ | ○ | ○ | ||
| Otologic Examination | ○ | |||||
| Acoustic Examination | ○ | ○ | ○ | ○ | ||
| Tinnitus Handicap Inventory | ○ | ○ | ○ | ○ | ||
| Visual Analogue Scale | ○ | ○ | ○ | ○ | ||
| EQ-5D | ○ | ○ | ○ | |||
| Health Utilities Index Mark 3 | ○ | ○ | ○ | |||
| Adverse Effects | ○ | ○ | ○ | |||
| Blinding Assessment | ○ | |||||
