The randomized, double-blind, placebo-controlled, multi-center trial enrolled 51 patients age 12 to 53 years, including 7 patients age 12 to 16 years, who were maintaining a regimen of maximally-tolerated lipid lowering medications.

FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia

Safety data for KYNAMRO are based on pooled results from four Phase 3, randomized, double-blind, placebo-controlled trials with a total of 390 patients of which 261 patients received weekly subcutaneous injections of 200 mg of KYNAMRO and 129 patients received placebo for a median treatment duration of 25 weeks.

FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia

It is because the government-funded trial was a placebo-controlled, double-blind, randomized controlled trial.

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