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。

youdao

Efficacy and Safety of Prophylactic Large Dose of Tranexamic Acid in Spine Surgery: a Prospective, Randomized, Double-Blind, Placebo-Controlled Study.

预防性大剂量氨甲环酸在脊柱外科中的疗效和安全性：一个前瞻性，随机，双盲，安慰剂对照的研究。

youdao

Presented here at the 132nd Annual Meeting of the American Neurological Association, the prospective, randomized, double-blind, placebo-controlled trial included 40 patients with poststroke aphasia.

在第132届美国神经病协会年会上公布的前瞻性、随机、双盲、安慰剂对照的该项试验共纳入了40名卒中后失语患者。

youdao

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.

FORBES