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All investigational groups also received gabapentin as background therapy PLB placebo, SAE serious adverse event, TRZ trazodone The most frequent treatment-emergent adverse events involved principally the nervous system disorders (28 events: ten in TRZ30, ten in TRZ60, and eight in PLB) and investigations (27 events: six in TRZ30, nine in TRZ60, and 12 in PLB) followed by gastrointestinal disorders (15 events: seven in TRZ30, three in TRZ60, and five in PLB), as summarized in Table 5