History of hypersensitivity, allergy or contraindication to opioids and acetaminophen

Confounding painful conditions

Significant vascular disease

History or risk of seizure

Chronic disease that might effect drug absorption, distribution, metabolism, or excretion

Female subjects who are being pregnant or breastfeeding

Evidence or history of alcohol, medication, or drug abuse

A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y