 Phase: Phase II, Phase IType: TreatmentStatus: ActiveAge: 18 and overSponsor: Pharmaceutical IndustryProtocol IDs: C34002, U1111-1163-2185, NCT02323113Phase: Phase IType: BiomarkerLaboratory analysis, TreatmentStatus: ActiveAge: 18 and overSponsor: Pharmaceutical IndustryProtocol IDs: C34001, 2013-002292-18, U1111-1165-3590, NCT02000934 