Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Ivacaftor-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, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive
Brief Summary: This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.


Options:
A: Arm Label: Riociguat (Adempas, BAY63-2521); Type: EXPERIMENTAL; Interventions: Drug: Riociguat (Adempas, BAY63-2521) | Arm Label: Placebo; Type: EXPERIMENTAL; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Riociguat (Adempas, BAY63-2521); Assigned to Arm(s): Riociguat (Adempas, BAY63-2521) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Treatment Sequence 1; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA, Drug: Placebo | Arm Label: Treatment Sequence 2; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA, Drug: Placebo | Intervention Type: DRUG; Name: LUM/IVA; Assigned to Arm(s): Treatment Sequence 1, Treatment Sequence 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Treatment Sequence 1, Treatment Sequence 2
C: Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 2: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: VX-121/TEZ/VX-561 TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: VX-121; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part 2: TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part 2: TEZ/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part 1: Placebo
D: Arm Label: Ivacaftor (Run-in Period); Type: EXPERIMENTAL; Interventions: Drug: Ivacaftor | Arm Label: VX-661 + Ivacaftor (Active comparator period); Type: EXPERIMENTAL; Interventions: Drug: Ivacaftor, Drug: Tezacaftor/Ivacaftor | Arm Label: Ivacaftor monotherapy (Active comparator period); Type: ACTIVE_COMPARATOR; Interventions: Drug: Ivacaftor | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Ivacaftor (Run-in Period), Ivacaftor monotherapy (Active comparator period), VX-661 + Ivacaftor (Active comparator period) | Intervention Type: DRUG; Name: Tezacaftor/Ivacaftor; Assigned to Arm(s): VX-661 + Ivacaftor (Active comparator period)

Answer: D