Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Controlled, Randomized, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837, Given as an Extended-release Formulation, in the Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
Brief Summary: The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.


Options:
A: Arm Label: dabigatran etexilate 75 mg; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate | Arm Label: dabigatran etexilate 110 mg; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate | Arm Label: enoxaparin; Type: ACTIVE_COMPARATOR; Interventions: Drug: enoxaparin | Intervention Type: DRUG; Name: dabigatran etexilate; Assigned to Arm(s): dabigatran etexilate 75 mg | Intervention Type: DRUG; Name: dabigatran etexilate; Assigned to Arm(s): dabigatran etexilate 110 mg | Intervention Type: DRUG; Name: enoxaparin; Assigned to Arm(s): enoxaparin
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: AZD0837 | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: AZD0837 | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: AZD0837 | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: AZD0837 | Arm Label: 5; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin-K antagonist at INR 2-3 | Intervention Type: DRUG; Name: AZD0837; Assigned to Arm(s): 1, 3, 4 | Intervention Type: DRUG; Name: Vitamin-K antagonist at INR 2-3; Assigned to Arm(s): 5 | Intervention Type: DRUG; Name: AZD0837; Assigned to Arm(s): 2
C: Arm Label: dabigatran etexilate 150 mg BID; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate 150 mg twice daily (BID) | Arm Label: matching placebo twice daily (BID); Type: PLACEBO_COMPARATOR; Interventions: Drug: matching placebo twice daily (BID) | Intervention Type: DRUG; Name: dabigatran etexilate 150 mg twice daily (BID); Assigned to Arm(s): dabigatran etexilate 150 mg BID | Intervention Type: DRUG; Name: matching placebo twice daily (BID); Assigned to Arm(s): matching placebo twice daily (BID)
D: Arm Label: Dabigatran etexilate; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate low dose, Drug: dabigatran etexilate intermediate dose, Drug: dabigatran etexilate high dose | Arm Label: warfarin; Type: ACTIVE_COMPARATOR; Interventions: Drug: warfarin 5mg, Drug: warfarin 1mg, Drug: warfarin 3mg | Intervention Type: DRUG; Name: dabigatran etexilate low dose; Assigned to Arm(s): Dabigatran etexilate | Intervention Type: DRUG; Name: warfarin 5mg; Assigned to Arm(s): warfarin | Intervention Type: DRUG; Name: dabigatran etexilate intermediate dose; Assigned to Arm(s): Dabigatran etexilate | Intervention Type: DRUG; Name: warfarin 1mg; Assigned to Arm(s): warfarin | Intervention Type: DRUG; Name: dabigatran etexilate high dose; Assigned to Arm(s): Dabigatran etexilate | Intervention Type: DRUG; Name: warfarin 3mg; Assigned to Arm(s): warfarin

Answer: B