definiens: means a clinical study of a drug candidate in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F .R. 312.21(c ), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United States . The relevant drug candidate may be administered to patients as a single agent or in combination with other investigatio nal or marketed agents 1.67 means a clinical study of a drug candidate in patients, performed after preliminary evidence suggesting efficacy of such product has been obtained, conducted for inclusion in ( a ) that portion of the FDA submission and approval process that provides for the continued trials of such product in sufficient numbers of human patients to confirm with statistical significance the safety and efficacy of such Licensed Product sufficient to support Regulato ry Approval in the proposed indication, as more fully defined in 21 C.F.R. § 312.21(c ) or ( b ) equivalent Regulatory Authority submissions in a country other than the United States