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 VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Brief Summary: This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.


Options:
A: Arm Label: Placebo (pooled two times a day [BID]/three times a day [TID]); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo two times a day (BID)/three times a day (TID) | Arm Label: AZLI (pooled two times a day [BID]/three times a day [TID]); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg two times a day (BID)/three times a day (TID); Assigned to Arm(s): AZLI (pooled two times a day [BID]/three times a day [TID]) | Intervention Type: DRUG; Name: Placebo two times a day (BID)/three times a day (TID); Assigned to Arm(s): Placebo (pooled two times a day [BID]/three times a day [TID])
B: Arm Label: Group 1-6d Combined: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo matched to VX-661, Drug: Placebo matched to ivacaftor | Arm Label: Group 1: VX-661 10 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661 | Arm Label: Group 2a: VX-661 30 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Placebo matched to ivacaftor | Arm Label: Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 3a: VX-661 100 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Placebo matched to ivacaftor | Arm Label: Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 5a: VX-661 150 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661 | Arm Label: Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 7: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ivacaftor, Drug: Placebo matched to VX-661 | Arm Label: Group 7: VX-661 100 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Intervention Type: DRUG; Name: VX-661; Assigned to Arm(s): Group 1: VX-661 10 mg qd, Group 2a: VX-661 30 mg qd, Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h, Group 3a: VX-661 100 mg qd, Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h, Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h, Group 5a: VX-661 150 mg qd, Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h, Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h, Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h, Group 7: VX-661 100 mg qd | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h, Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h, Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h, Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h, Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h, Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h, Group 7: Placebo, Group 7: VX-661 100 mg qd | Intervention Type: DRUG; Name: Placebo matched to VX-661; Assigned to Arm(s): Group 1-6d Combined: Placebo, Group 7: Placebo | Intervention Type: DRUG; Name: Placebo matched to ivacaftor; Assigned to Arm(s): Group 1-6d Combined: Placebo, Group 2a: VX-661 30 mg qd, Group 3a: VX-661 100 mg qd
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: VX-661 Plus Ivacaftor Combination Placebo, Drug: Ivacaftor placebo | Arm Label: VX-661/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-661 Plus Ivacaftor Combination, Drug: Ivacaftor | Intervention Type: DRUG; Name: VX-661 Plus Ivacaftor Combination; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: VX-661 Plus Ivacaftor Combination Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Ivacaftor placebo; Assigned to Arm(s): 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: C