definiens: shall mean any human clinical trial where the principal purpose is to determine preliminary evidence of efficacy and safety or to t : stablish a dose or dose range for Phase III chnical1rials of a Licensed Product in a patient population that has the disease or condition being studied ( for example as described in 21 C.F.R. § 312,.21 ( b ) or, with respect to a ju'risdiction other than the United States . a similar clinical study ) . ' 1 .71 shall mean any human clinical trial that is intended to be a pivotal trial for'seeking or obtaining a M ~ eting Approval or to otherwise e ~ hli!\h safety and efficac } ' in patients with the indication being studied for purposes of filing an MAA ( for example, as described in 2l C.F.R. § 312.21(c ), Of, with respect to a. jurisdiction other than the Unhcd Sttltes, a similar clinical study )