definiens: means a human clinical trial of a product on a su fficient number of subjects that, prior to commencement of the trial, satisfies both of the following ( ( a ) and ( b ) ): ( a ) such tria l is designed to establish that such product has an acceptable safet y and efficacy profile for its intended use, and to determine warnings, precautions, and adverse reactions that a re associated with such product in the dosage range to be prescribed, which trial is intended to support Mark eting Authorization of such product, or a similar c linical study prescribed by a Regulatory Authority ; and ( b ) such trial is a registration trial sufficient for filing an application for a Marketing Authorization for such product in t he U.S. or another country or some or all of an ext ra - national territory, as evidenced by ( i ) an agreement with or statement from the FDA on a Special Protocol Asses sment, or ( ii ) other guidance or minutes issued by a Regulato ry Authority, for such registration trial