Background
UNITI, Tinnitus, tinnitus
DISEASE, TINNITUS, TINNITUS
Tinnitus is a common condition associated with a high global disease burden. Currently, there is no universal treatment or cure for tinnitus [A study protocol for UNITI-RCT has previously been published [The UNITI-RCT is executed in five clinical centers across the EU. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis. The already published study protocol delineates the rationale and methods of the study, its population plus the respective inclusion and exclusion criteria, the description of outcome measures, collected covariates, and the used interventions. As a follow-up to the study’s protocol, this statistical analysis plan (SAP) aims to further describe the statistical techniques in more detail used to address the primary objectives of the RCT. To increase the transparency of data analysis, this plan will be made public before database closure (UNITI website: 