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Table 3 Exclusion criteria of UNITI-RCT as specified in the study protocol [1]

From: The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)

Exclusion criteria

 Objective tinnitus or heartbeat- synchronous tinnitus as primary complaint

 Otosclerosis/acoustic neuroma or other relevant ear disorders with fluctuation hearing

 Present acute infections (acute otitis media, otitis externa, acute sinusitis)

 Meniere's disease or similar syndromes with the exception of vestibular migraine

 Serious internal, neurological or psychiatric conditions

 Epilepsy or other central nervous system disorders (brain tumor, encephalitis)

 Clinically relevant drug, medication or alcohol abuse up to 12 weeks before study start

 Severe hearing loss as defined by the inability to communicate properly in the course of the study

 At least one deaf ear

 Missing written informed consent

 Start of any other tinnitus-related treatments, especially hearing aids, structured counseling, sound therapy (with special devices; expecting long-term effects) or cognitive behavioral therapy in the last 3 months before the start of the studya

  1. aIf a HA has already been worn 3 months before screening, eligible candidates are allowed to participate, but are automatically assigned to the group with no HA indication