The approval was based on data from 2 prospective, randomized, double-blind placebo-controlled clinical studies.

这次批准的依据是2次前瞻性随机双盲安慰剂控制对照临床研究的数据。

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The double-blind, randomized, placebo-controlled study included 24 patients ages 48 to 84.

该双盲随机严格对照试验纳入了24名48到84岁的患者。

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Methods a multicenter, double-blind, randomized controlled trial was conducted.

方法用多中心随机双盲对照试验。

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

FORBES

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