definiens: means a human clinical tria l of a product that is on a sufficient number of subjects that, prior to commencement of the trial, satisfies both of the following ( ( a ) and ( b ) ): ( a ) such trial, together with other availabl e evidence from prior clinical trials, is prospectively designed to establish that such produ ct has an acceptable safety and efficacy profile fo r its intended use, and to determine warnings, precaution s, and adverse reactions that are associated with s uch product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval o f such product in the United States, the European Union or Japan and will provide substantial evidence of saf ety and effectiveness for reliance by Regulatory Authoritie s in granting Regulatory Approval ; and ( b ) such trial is prospectively designed to be a registration trial sufficient, together with other available evidence from prior c linical trials, for submitting an application for R egulatory Approval for such product in the United States, the European Union or Japan, as evidenced by ( i ) an ag reement with or statement from the FDA, EMA or PMDA on a sp ecial protocol assessment or equivalent, or ( ii ) ot her guidance or minutes issued by the FDA, EMA or PMDA, for such registration trial