 The patient was excluded if heshe had any serious medical conditions or conditions that may have presented a safety concern or that may have impacted efficacy assessment, eg, taking drugs like antidepressants known to affect RLS. Medical conditions included, but were not limited to: claudication, nerve problems, fragile, thin skin, impaired wound healing; poor circulation, injury to feet or legs, movement problems, inability to sit still or remain motionless, involuntary movements similar to a tic, sleep disorders, parasomnias involving abnormal movements, narcolepsy, obstructive sleep apnea, nighttime discomfort not due to RLS, secondary RLS, or Parkinsons Disease. Patients on drug treatment for RLS must have been discontinued treatment for at least 30 days. Note: None of our patients were on drug treatment for RLS. Through history and physical examination, the physician distinguished RLS from other disorders such as periodic Limb Movement Disorder footnote 5 