[Translation] A 14-week, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of pregabalin in the treatment of fibromyalgia
1. 在纤维肌痛相关疼痛症状缓解上,与安慰剂对照评估普瑞巴林可变剂量(300 - 450 mg/日)一日两次的疗效;2. 如果达到了第一个研究目的,则第二个主要研究目的旨在评估与安慰剂对照普瑞巴林(一日两次)治疗纤维肌痛(疼痛减轻、患者整体评价和功能改善)的疗效。
[Translation] 1. To evaluate the efficacy of pregabalin (300 - 450 mg/day) twice daily compared with placebo in relieving fibromyalgia-related pain symptoms; 2. If the first study objective is achieved, the second primary study objective is to evaluate the efficacy of pregabalin (twice daily) compared with placebo in the treatment of fibromyalgia (pain reduction, patient global assessment and functional improvement).