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: 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
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: 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])
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