definiens: means a Clinical Trial of a Licensed Product with a defined dose or a set of defined doses of such Lice nsed Product and conducted by or on behalf of Taked a, its Affiliates or Sublicensees on a sufficient number o f subjects for ascertaining ( and that is designed t o ascertain ) the overall risk - benefit relationship of the Licensed P roduct for its intended use and determining ( and to determine ) warnings, precautions, and adverse reactions that a re associated with such Licensed Product in the dos age range to be prescribed, in a manner that is generally con sistent with 21 C.F.R. § 312.21(c ), as amended ( or its successor regulation ), or a similar clinical study prescribed by the Regulatory Authorities in a country or juri sdiction outside the United States, which trial is necessary to supp ort Regulatory Approval of such Licensed Product, e xcluding, for clarity any investigator - initiated Clinical Tri als