“…(1) participation in another clinical trial within 30 days beforehand, (2) actual or possible pregnancy, or lactation, (3) any suspicion of drug or alcohol abuse, (4) history of allergy to the study medication, (5) any severe chronic disease, (6) any current pain treatment--whether analgesics or nonsteroidal analgesics (NSAIDs), (7) treatment with steroids, oro-pharyngeal therapeutic agents, anticonvulsants, psychotropic or immunosuppressant agents within 24 h (or, with prolonged action NSAIDs, within 10 days), or antibiotics within the 14 days up to enrollment, (8) known or suspected bacterial infection, (9) known or suspected NADH-diaphorase deficiency. After patients had given informed written consent, their age and gender were recorded along with their medical and surgical history and the results of a general physical examination that included their height, weight, sitting blood pressure and heart rate.…”