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 | â—‹ | |||||
Demographic Characteristics | â—‹ | |||||
Medical History | â—‹ | |||||
Safety Assessment | â—‹ | â—‹ | â—‹ | â—‹ | ||
Otologic Examination | â—‹ | |||||
Acoustic Examination | â—‹ | â—‹ | â—‹ | â—‹ | ||
Tinnitus Handicap Inventory | â—‹ | â—‹ | â—‹ | â—‹ | ||
Visual Analogue Scale | â—‹ | â—‹ | â—‹ | â—‹ | ||
EQ-5D | â—‹ | â—‹ | â—‹ | |||
Health Utilities Index Mark 3 | â—‹ | â—‹ | â—‹ | |||
Adverse Effects | â—‹ | â—‹ | â—‹ | |||
Blinding Assessment | â—‹ |