| Pre-screening | Screening | Baseline | Treatment start | Interim visit | Final visit = end of treatment | Follow-up | Additional follow-up |
---|---|---|---|---|---|---|---|---|
ICF | Aa | A | Â | Â | Â | Â | Â | Â |
Eligibility criteria | A | A | A | Â | Â | Â | Â | Â |
ESIT-SQ | Â | Â | A | Â | Â | Â | Â | Â |
TSCHQ | Â | Â | B | Â | Â | Â | Â | Â |
Mini TQ | A | A | A | Â | A | A | A | B |
Tinnitus numeric rating scales | Â | A | A | Â | A | A | A | B |
TFI | Â | A | A | Â | A | A | A | B |
THI | A | A | A | Â | A | A | A | B |
WhoQol-BREF | Â | A | A | Â | A | A | A | B |
BFI-2 | Â | Â | A | Â | Â | Â | Â | Â |
CGI-I | Â | Â | Â | Â | A | A | A | B |
GUF | Â | B | B | Â | B | B | B | B |
PHQ-D | A | A | A | Â | A | A | A | B |
Mini-SOISES | Â | Â | A | Â | A | A | A | B |
ATAQ | Â | Â | Bb | Â | Â | Bb | Â | Â |
FTQ | Â | Â | B | Â | B | B | B | B |
MoCA | Â | A | Â | Â | Â | Â | Â | Â |
Randomization | Â | Â | A | Â | Â | Â | Â | Â |
Blood sampling | Â | Â | Bc | Â | Â | Â | Â | Â |
Otological examination | Â | A | Â | Â | Â | A | B | B |
Audiometry | Â | A | Â | Â | Â | A | B | B |
Loudness match | Â | A | Â | Â | Â | A | B | B |
Pitch match | Â | A | Â | Â | Â | A | B | B |
Maskability | Â | A | Â | Â | Â | A | B | B |
Residual inhibition | Â | A | Â | Â | Â | B | B | B |
ABR | Â | Â | A | Â | Â | Â | B | B |
AMLR | Â | Â | A | Â | Â | Â | B | B |
Treatment | Â | Â | Â | A | A | A | Â | Â |
Comorbidities | Â | A | A | A | A | A | A | B |
Concomitant medication/ treatment | Â | A | A | A | A | A | A | B |
Adverse events | Â | Â | Â | Â | A | A | A | B |