- Males or females at least 18 years of age, of any ethnic origin
- Type 1 or 2 diabetes mellitus
- Pain score greater than or equal to 4 on the 11-point numeric pain rating scale
- Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the
assessment of neuropathic pain.
- Presence of severe pain associated with conditions other than diabetic peripheral
neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.