definiens: shall mean a clinical tr ial in a human patient population that is sufficien t to support Regulatory Approval in the proposed indicat ion, as more fully defined in 21 C.F.R. § 312.21(c ), as amended ( or its successor regulation ) and that is d esigned to obtain data determining efficacy and saf ety of a pharmaceutical product to support such Regulatory A pproval, or a similar clinical study prescribed by a Regulatory Authority outside the United States ; pro vided, however, that the FDA permits the treatment of patients in the U.S. under an open IND in such clin ical trial ; and provided, further, that treatment o f patients for compassionate use, including in an expanded access program, single patient program or named patient pr ogram shall not be included in determining whether or not a clinical trial is a Phase III Clinical Trial or whether a patient has been dosed thereunder