definiens: means a study of a Product in human patients designed or intended to determine initial efficacy, pharmacological effect or dose range or regimen, as further defined in 21 C.F.R. 312.21(b ), as amended from time to time, or thecorresponding regulations in any jurisdiction or country other than the United States, or any amended or successor regulations, to permit thedesign of further clinical trials, including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a ) ( orcorresponding foreign regulations ) and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b ) ( orcorresponding foreign regulations ) or otherwise to enable a Pivotal Clinical Trial ( e.g., a phase 1/2 trial ) but only at the time of Initiation of theoptimized or expanded portion of such trial