Two randomized controlled trials (RCTs), one before-and-after study and two retrospective reports on clinical efficacy and safety were retrieved, together with 18 pharmacokinetic studies.

检索到与临床功效和安全性相关的两个随机对照试验(rct)、一个前后对照研究、两个回顾性报告，以及18个药物动力学研究。

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Methods: a multicenter, randomized, double blind, and placebo controlled clinical study was performed.

方法本次为一中心，随机，双盲，安慰剂对照临床观察。

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Various forms may be employed for the study design of this phase in accordance with the specific study purpose, including randomized controlled clinical trial.

此阶段的研究设计可以根据具体的研究目的，采用多种形式，包括随机盲法对照临床试验。

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For one, the groups noted the analysis is a retrospective study, not a prospective, randomized controlled clinical trial, which many regard as a gold standard for ferreting out safety concerns.

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