definiens: means a registr ation or pivotal clinical trial performed in subjects with a particular disease or condition tha t is designed in a randomized, controlled fashion t o establish the dose, efficacy and safety of a product given its in tended use and to define warnings, precautions and adverse events that are associated with such product in the dosage range intended to be prescribed . This clinical tri al may be conducted in lieu of conducting a separate that would otherwise satisfy the r equirements of 21 C.F.R. § 312.21(b ) ( or its equivalent under the applicable Laws of any country in the Ex - U.S. Terri tory ) and that would otherwise satis fy the requirements of 21 C.F.R. § 312.21(c ) ( or it s equivalent under the applicable Laws of any country in the Ex- U.S. Territory ) and may be bridged to larger studie s. For clarity, a substudy of an existing Phase III Clinic al Trial that is used as a pivotal study for a part icular disease or condition shall constitute a Phase III Clinical Tri al