definiens: means the prevention, treatment, or amelioration of : ( i ) any cardiovascular disease or condition ; ( ii ) any r enal disease or condition ; ( iii ) any neurological, psychiatric, or neuropsychiatric disorders or conditions ( other tha n diabetic neuropathy ) ; or ( iv ) disorders of the co rneal endothelium, in each case ( ( i ) – ( iv ) ), excluding t he prevention, treatment, or amelioration of : ( A ) any forms of cancer ; ( B ) any forms of organ failure ( other than renal failure or heart failure ) ; ( C ) respiratory di sorders ; ( D ) allergies and autoimmune diseases ( other than lupus nephritis ) ; ( E ) infectious diseases ; ( F ) skin dise ases ( other than diabetic ulcers ) ; ( G ) gastrointestinal disorde rs ; ( H ) bone or cartilage disorders ; ( I ) musculoske letal disorders ; ( J ) eye diseases ( other than diabetic retinopathy a nd disorders of the corneal endothelium ) ; ( K ) human immunodeficiency virus - associated complications ; an d ( L ) sepsis