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. 2008 Apr 15;8:23. doi: 10.1186/1471-244X-8-23

Table 1.

Study Plan

Screening Baseline R3 Treatment Follow-Up
Visits V0 V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 V13 final visit4

Week Week 0 Week 1 Week 2 Week 3 Week 10 Week 26/PTV

Day - 11 to -9 1 2 3 4 5 8 9 10 11 12 17 – 19 66–68 180 – 182
Rating Scales (THI) X1 X2 X X X X X
Otologic examination and audiological assessment X1 X
Informed Consent X
Demographic Data X
Medical History X
Documentation of Comorbidity X X
Documentation of concomitant medication X X X X X X
Physical examination X X X
Vital Signs X X X X
Rating Scales (Goebel&Hiller, BDI, SF 12) X2 X X X X X
Tinnitus-Severity X X X X X X X
NEO FFI, RS-11 X
CGI X X X X X X X
Neuropsychological Assessment X X
Cortical Excitability (pTMS) X X
Structural Neuroimaging (VBM) X X
Inclusion/Exclusion X
Randomization X
rTMS Treatment X X X X X X X X X X
Documentation of Adverse Events X X X X X X X X X X

1 = results of routine clinical investigations

2 = each patient receives at V1 two versions of THI and TQ to be completed on Monday and Friday before V2

3 = randomisation

4 = Visit 14 or PTV = Premature Termination Visit