definiens: means a clinical trial in humans of a product per formed to gain evidence with statistical significance of the effic acy of such product in a target population, and to obtain expanded evidence of safety for such product that i s needed to evaluate the overall benefit - risk relat ionship of such product, to form the basis for Regulatory Appr oval by a Regulatory Authority and to provide an ad equate basis for physician labeling, as described in 21 C. F.R. 312.21(c ), as amended from time to time, or th e corresponding regulations in jurisdictions other th an the United States whether or not such clinical t rial results in a filing for Regulatory Approval . Any clinical tria l conducted under a protocol which identifies such trial as a or trial shall be deemed to be a Registration Study . Any clinical trial conducted under a protocol which identifies such trial as a trial shall be deemed to be a Registration Study upon dosing of the first patient in the Phase 3 portion of such trial ( which shall also be deemed to be the Initia tion of such Registration Study )