definiens: means the first to occur of : ( i ) demonstration of positive pharmacokinetic andsafety results in a Clinical Trial conducted anywhere in the world, as evidenced by demonstration of the following for a D - DMProduct : a ) steady - state area under the curve ( AUC ) plasma concentrations of a D - DM Product of at least [ * * ] percent of thesteady - state AUC plasma concentrations of the comparator drug, and b ) minimum plasma concentrations of a D - DM Productof at least [ * * ] % of the minimum plasma concentrations of the comparator drug, and c ) maximum plasma concentrations of aD - DM Product of no more than [ * * ] -fold greater than the maximum plasma concentrations of the comparator drug, and d)safety profile of a D - DM Product which is similar or more favourable to the comparator drug . For purposes of this definition, shall be defined as plasma concentrations following at least [ * * ] days of dosing, shallmean either a D - DM Only Product or a D - DM and Quinidine Product, as applicable, and the comparator drug is [ * * ] mg ofdextromethorphan combined with [ * * ] mg of quinidine dosed with the same frequency as the D - DM Product ; or ( ii ) initiationof first dosing of a patient in a Phase 2 Clinical Trial