definiens: means, with respect to a prod uct, a use to which such product is intended to be put for the treatment, prevention, mitigation, cure or diagnosis of a recognized disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a re cognized disease or condition, in each case for any size pat ient population, which, ( a ) for a Clinical Trial fo r such product, would be the use of such product for which such Cli nical Trial is intended to determine safety or effe ctiveness and ( b ) if such product is approved in the U.S., would be reflected in the section of labeling pursuant to 21 C.F.R. § 201.57(c)(2 ) or, to the exte nt applicable, any comparable labeling section outs ide the U.S., in each case ( ( a ) and ( b ) ), subject to the followin g : ( i ) subtypes of the same disease or condition ar e not additional Indications for such product ; ( ii ) different sympto m domains or domains of impairment of the same dise ase or condition are not additional Indications for such p roduct, for the further avoidance of doubt, compone nts of neurobehavioral symptom domains of such disease, su ch as agitation, restlessness and aggression, are t he same 12 Indication, even if separate pivotal trials are req uired for approval of each such symptom ; ( iii ) the approved use of such product for such disease in different combinat ions or co - therapies of treatments are not addition al Indications for such product ( e.g., monotherapy vs. add - on or combination therapy wit h another agent in the same disease ) ; ( iv ) treatment, prevention and cure of the same dis ease or disease subtype with such product are not a dditional Indications for such product ; ( v ) the approved use of such product for such disease in a different lin e of treatment or a different temporal position in a treatment alg orithm for the same disease or condition are not ad ditional Indications for such product ( e.g., first line vs. second line therapy in the same di sease or condition ) ; and ( vi ) treatment of the same disease or condition with suc h product in an expanded, modified or additional pa tient population are not additional Indications for such product