Efficacy evaluation
tinnitus loudness, tinnitus
TINNITUS
Efficacy assessments included the TFI (completed at Screening, Baseline (Day 1), Weeks 4, 8, 12, and 16), and the Patient Global Impression of Change to evaluate overall “global” tinnitus status as perceived by the patient (completed at Weeks 4, 8, 12, and 16). Daily ratings of tinnitus loudness and tinnitus annoyance utilizing numeric rating scales from 0 to 10 were completed each day between 6 p.m. and midnight using a smart phone.