Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Brief Summary: The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: LUM 600 mg qd/IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Intervention Type: DRUG; Name: Lumacaftor Plus Ivacaftor Combination; Assigned to Arm(s): LUM 400 mg q12h/ IVA 250 mg q12h, LUM 600 mg qd/IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): LUM 600 mg qd/IVA 250 mg q12h | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-809, Drug: VX-770 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: VX-809; Assigned to Arm(s): LUM/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: VX-770; Assigned to Arm(s): LUM/IVA
C: Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-659/TEZ/IVA) | Arm Label: Part 1: VX-659/TEZ/IVA TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 1: VX-659/TEZ/IVA TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 1: VX-659/TEZ/IVA TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: VX-659/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-659/TEZ/VX-561) | Arm Label: Part 3: VX-659/TEZ/VX-561 TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: VX-659; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: VX-659/TEZ/IVA TC, Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: TEZ/IVA, Part 2: VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: TEZ/IVA, Part 2: VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: Placebo (matched to VX-659/TEZ/IVA); Assigned to Arm(s): Part 1: Placebo | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: Placebo (matched to VX-659/TEZ/VX-561); Assigned to Arm(s): Part 3: Placebo
D: Arm Label: VX-661/Ivacaftor combination; Type: EXPERIMENTAL; Interventions: Drug: VX-661/Ivacaftor, Drug: Ivacaftor, Drug: Placebo matched to Ivacaftor | Arm Label: Ivacaftor monotherapy; Type: EXPERIMENTAL; Interventions: Drug: Ivacaftor, Drug: Placebo matched to VX-661/ ivacaftor | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo matched to VX-661/ ivacaftor, Drug: Placebo matched to Ivacaftor | Intervention Type: DRUG; Name: VX-661/Ivacaftor; Assigned to Arm(s): VX-661/Ivacaftor combination | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Ivacaftor monotherapy, VX-661/Ivacaftor combination | Intervention Type: DRUG; Name: Placebo matched to VX-661/ ivacaftor; Assigned to Arm(s): Ivacaftor monotherapy, Placebo | Intervention Type: DRUG; Name: Placebo matched to Ivacaftor; Assigned to Arm(s): Placebo, VX-661/Ivacaftor combination

Answer: A