Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation


Options:
A: 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
B: 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
C: Arm Label: 10 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 50 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 50 mg (single dose); Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 250 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 250 mg (Fed); Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 500 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Placebo-Day 1 only; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo-Day 1 only | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): 10 mg, 250 mg, 50 mg, 500 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): 250 mg (Fed), 50 mg (single dose) | Intervention Type: DRUG; Name: Placebo-Day 1 only; Assigned to Arm(s): Placebo-Day 1 only
D: 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

Answer: A