Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins
Brief Summary: This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.


Options:
A: Arm Label: Placebo Q2W; Type: PLACEBO_COMPARATOR; Interventions: Drug: Alirocumab, Drug: Placebo (for Alirocumab), Drug: Non-statin LMT, Other: Diet Alone | Arm Label: Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator); Type: OTHER; Interventions: Drug: Alirocumab, Drug: Non-statin LMT, Other: Diet Alone | Arm Label: Alirocumab 150 mg Q4W/Up to 150 mg Q2W; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Placebo (for Alirocumab), Drug: Non-statin LMT, Other: Diet Alone | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab 150 mg Q4W/Up to 150 mg Q2W, Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator), Placebo Q2W | Intervention Type: DRUG; Name: Placebo (for Alirocumab); Assigned to Arm(s): Alirocumab 150 mg Q4W/Up to 150 mg Q2W, Placebo Q2W | Intervention Type: DRUG; Name: Non-statin LMT; Assigned to Arm(s): Alirocumab 150 mg Q4W/Up to 150 mg Q2W, Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator), Placebo Q2W | Intervention Type: OTHER; Name: Diet Alone; Assigned to Arm(s): Alirocumab 150 mg Q4W/Up to 150 mg Q2W, Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator), Placebo Q2W
B: Arm Label: Atorvastatin (statin rechallenge arm); Type: OTHER; Interventions: Drug: Atorvastatin, Drug: Placebo | Arm Label: Ezetimibe; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ezetimibe, Drug: Placebo | Arm Label: Alirocumab 75 mg/ up to 150 mg; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Placebo | Intervention Type: DRUG; Name: Atorvastatin; Assigned to Arm(s): Atorvastatin (statin rechallenge arm) | Intervention Type: DRUG; Name: Ezetimibe; Assigned to Arm(s): Ezetimibe | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab 75 mg/ up to 150 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Alirocumab 75 mg/ up to 150 mg, Atorvastatin (statin rechallenge arm), Ezetimibe
C: Arm Label: Part A: Atorvastatin 20 mg => Placebo; Type: OTHER; Interventions: Drug: Atorvastatin, Drug: Placebo to Atorvastatin | Arm Label: Part A: Placebo => Atorvastatin 20 mg; Type: OTHER; Interventions: Drug: Atorvastatin, Drug: Placebo to Atorvastatin | Arm Label: Part B: Ezetimibe; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ezetimibe, Other: Placebo to Evolocumab | Arm Label: Part B: Evolocumab; Type: EXPERIMENTAL; Interventions: Other: Placebo to Ezetimibe, Drug: Evolocumab | Arm Label: Part C: Open-label Evolocumab; Type: EXPERIMENTAL; Interventions: Drug: Evolocumab | Intervention Type: DRUG; Name: Atorvastatin; Assigned to Arm(s): Part A: Atorvastatin 20 mg => Placebo, Part A: Placebo => Atorvastatin 20 mg | Intervention Type: DRUG; Name: Placebo to Atorvastatin; Assigned to Arm(s): Part A: Atorvastatin 20 mg => Placebo, Part A: Placebo => Atorvastatin 20 mg | Intervention Type: OTHER; Name: Placebo to Ezetimibe; Assigned to Arm(s): Part B: Evolocumab | Intervention Type: DRUG; Name: Ezetimibe; Assigned to Arm(s): Part B: Ezetimibe | Intervention Type: OTHER; Name: Placebo to Evolocumab; Assigned to Arm(s): Part B: Ezetimibe | Intervention Type: DRUG; Name: Evolocumab; Assigned to Arm(s): Part B: Evolocumab, Part C: Open-label Evolocumab
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (for alirocumab), Drug: Lipid-Modifying Therapy (LMT) | Arm Label: Alirocumab; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Lipid-Modifying Therapy (LMT) | Intervention Type: DRUG; Name: Placebo (for alirocumab); Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab | Intervention Type: DRUG; Name: Lipid-Modifying Therapy (LMT); Assigned to Arm(s): Alirocumab, Placebo

Answer: B