Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.


Options:
A: 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
B: 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: Placebo; Assigned to Arm(s): Placebo | 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
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 150 mg Ivacaftor q12h; Type: EXPERIMENTAL; Interventions: Drug: Ivacaftor | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): 150 mg Ivacaftor q12h | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 5 Part A: Observational Cohort; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 7 Part B: Placebo - 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): Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h, Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h, Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h, Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h, Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h, Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h, Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h

Answer: D