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 inthe dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, or a similarclinical study prescribed by the U.S. or EMA ; and(b ) such trial is a registration trial sufficient to support the filing of an application for a Regulatory Approvalfor such product in the U.S. or another country or some or all of an extra - national territory, as evidenced by ( i ) anagreement with or statement from the FDA or the EMA on a Special Protocol Assessment or equivalent, or ( ii ) otherguidance or minutes issued by the FDA or EMA, for such registration trial