definiens: " shall mean 11 clinical trial of a Ucenscd Product in humnn patients . which trial is designed ( a ) 10 establish that the Licemed Product iJ safe and efficacious fOl ' its intended use . ( b ) to define warnings . precautions and ach'e~ rcOClions that are associated with soch Licensed Product in the dosage range to be pn::scnbed, ( C ) to be . either by itself 01 ' together with 01lC or more other Clinical Trials IIaving a oompanible design and Size, the final human ClilllcaJ Trial in support of Regulatory Approval of D Mar'leting Authorization application of soch Licensed Product . and ( d ) consistent with 21 U.S. CFR f 312.21(c ) . shall not mclude a Phase ! lib Trial, 1.34 h1lSll 1111 ) Clinical Trial " shall mean a clinical trial of a Licen.~d ProdUCt in human patie!1l5, which provid~ { or product suppon ( i.e .. a clinical trial wh, ch is nOC required for receipt of initial Markcting Authorization but which llIay be useful in providing additional drug profilc data or 111 seeking a labcl e ~ pansion ) commenced before receipt of Marketing Authorization for the indicution for which such trial is beiog conducted