definiens: means a human clinical trial of a product on a sufficientnumber 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 acceptablesafety and efficacy profile for its intended 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 RegulatoryApproval of such product, or a similar clinical study prescribed by the FDA orEMA ; and(b)such trial is a registration trial sufficient for filing an application for aRegulatory Approval for such product in the U.S. or another country or some or allof an extra - national territory, as evidenced by ( i ) an agreement with or statementfrom the FDA or the EMA on a Special Protocol Assessment or equivalent, or ( ii)other guidance or minutes issued by the FDA or EMA, for such registration trial