definiens: shalllmeanclinical trialsinasmallsample oftheintended patient population commencing uponthefilingofatrialprotocol withtheappropriateregulatory bodyanddesigned toassesstheefficacy foraspecific indication ofacompoundproposed tobeusedasatherapeutic ordiagnostic pharmaceutical product, todetermine dosetolerance andtheoptimal doserangeaswellastogatheradditional information relating tosafetyandpotential adverse effects, andmeeting therequirements established bytheFDAortheequivalent Japanese agency forPhaseIIclinical trials . Thecompletion ofthePhaseIIClinicalTrialswillbedeemed tohaveoccurred uponthefirstformal internal issuance oftrialresults as4measured bytrialobjectives, orinanyeventnolaterthanthecommencement ofthePhaseillClinical Trials