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 trial is d esigned to establish that such product has an accep table safety and efficacy profile for its intended use, and to deter mine warnings, precautions, and adverse reactions t hat are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, or a similar clinical stu dy prescribed by the FDA or EMA ; and ( b ) such trial is a registration trial sufficient for filing an applic ation for a Regulatory Approval for such product in a Major Mar ket Country, as evidenced by ( i ) an agreement with or statement from the FDA or the EMA on a Special Prot ocol Assessment or equivalent, or ( ii ) other guidan ce or minutes issued by the FDA or EMA, for such registra tion trial