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ODYSSEY MONO (N=103) was a randomized, double-blind, active-controlled, parallel-group study to evaluate the efficacy and safety of alirocumab over 24 weeks in patients with primary hypercholesterolemia and moderate cardiovascular risk. Patients in the trial were randomized to receive monotherapy with either ezetimibe 10 mg, an alternative to statin therapy, or alirocumab. Alirocumab was self-administered initially at its low dose of 75 mg every two weeks, and was up-titrated at week 12 to 150 mg if the LDL-C measurement at week 8 was above 70 mg/dL. The majority of alirocumab patients in the trial remained on the initial low dose of alirocumab because they achieved LDL-C below 70 mg/dL at week 8. Alirocumab was self-administered subcutaneously using a single 1 milliliter (mL) auto-injector.
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