definiens: shall mean a clinical trial which includes the following, as specified in the protocol for such clinical trial : ( a ) Patient genotyping with respect to allelic variants of the genes in the pathways involved and/or activated bytbe Selected Compound ; ( b ) Comprehensive information on pedigree of relatives ( ) f patientsin the trial such as inheritance of disease, including genotype of selected relatives, where iIldicated ; ( c ) Comprehensive patient history data ; ( d ) Complete characterization at baseline by laboratory tests relevant to the disease ; 7 SLl 42621Ov2/95641.003 ( e ) Characterization of drug response with respect to the primary and multiple secondary endpoints ; ( f ) RNA obtained from relevant tissues of aU patients ( unless not feasible under the protocol ) including but not limited to blood and adipose tissue ; and ( g ) Integration of the foregoing information in a database in a manner that will permit analysis using appropriate software