definiens: means a human clinical trial of a product on a sufficient number of subjects that, prior to commencement of the trial, satisfies both of the following ( ( a ) and ( b)):(a)such trial is designed to establish that such product has an acceptable safety and efficacy profile for itsintended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in thedosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, or a similar clinicalstudy prescribed by the FDA or EMA ; and(b)such trial is a registration trial sufficient for filing an application for a Regulatory Approval for such productin the U.S. or another country or some or all of an extra - national territory, as evidenced by ( i ) an agreement with orstatement from the FDA or the EMA on a Special Protocol Assessment or equivalent, or ( ii ) other guidance or minutesissued by the FDA or EMA, for such registration trial