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Total daily doses greater than 500 mg have not been tapentadol studied and are not recommended .
· An adequate battery of genotoxicity studies comprised an tapentadol in vitro bacterial reverse mutation assay, in vitro mammalian chromosome aberration assays and an in vivo mammalian chromosome aberration assay and unscheduled DNA synthesis assay .
One study was performed in subjects with chronic pain due to osteoarthritis (KF09), and one study in subjects with chronic low tapentadol back pain (KF10) .
In making this recommendation, the ACPM considered the guidance on study design provided in the TGA accepted EU guideline on tapentadol nociceptive and neuropathic pain and advised that the available studies did not adequately demonstrate efficacy in the appropriate population .

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