History and physical examination and laboratory testing confirmed the absence of comorbid conditions including clinically evident
distal symmetrical neuropathy by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, 10-g
monofilament fiber, and ankle reflexes), abnormal lipid levels (including levels in people treated with statins or not treated with statins)
(total cholesterol levels, >200; LDL-cholesterol level, >130; or triglyceride level, >250), abnormal cardiac function or evidence of
ischemic heart disease by history, or abnormal resting or exercise ECG.