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  • According to previous clinical results, we assumed the proportion of patients demonstrating a decrease in NT-proBNP Staurosporine level of at least 30% in the placebo group would be 40%, 12% lower than the tested group. Therefore, given a type I error rate of alpha?= 0.05, a power of 80% (type II error rate of beta?= 0.2), the sample size for 1 arm needed to be 213, resulting in n?= 2?�� 213?=?426 patients. Moreover, considering a dropout rate of approximately 20% for randomized patients, a total of 512 patients (256 per treatment group) needed to be randomized to achieve the required number of patients for the efficacy analysis. Under these 2 assumptions, we recruited 512 patients to the study, who were subsequently allocated at a 1:1 ratio to the qili qiangxin capsule group or the placebo group. All statistical analyses were performed with SAS software, version 9.2 (SAS Institute, Cary, North?Carolina). Data from all patients who underwent randomization were analyzed according to the full analysis set?principle. Continuous variables are presented as the mean?�� SD. The comparability of the characteristics between the 2 study groups was assessed using a 2-sample Student t test for continuous variables and the chi-square test or Wilcoxon test, when appropriate, for categorical variables. The Wilcoxon paired signed-rank test?was used for within-group comparisons. Values of < 0.05 were considered statistically significant, and all tests were 2?tailed. From September 2011 to July 2012, 512 patients underwent randomization at 23 sites in China; the flow diagram of patients through the study is presented in Figure?1. The baseline characteristics of the study groups are shown in Table?1. EPZ5676 datasheet The mean age of the total population was 57.25 years, and 75.36% were male. The average course of CHF was 77.2 months. The CHF etiologies included cardiomyopathy (56.82%), ischemic heart disease (32.59%), hypertension (19.76%), and other conditions (2.24%). The distributions of the demographic and clinical characteristics between the qili qiangxin capsule group and the placebo group were well balanced and homogeneous. A favorable effect of qili qiangxin capsules was LY2109761 order observed on the plasma NT-proBNP level (Table?2). After 12 weeks of treatment, both groups showed a significant decrease in NT-proBNP levels from baseline, but treatment with qili qiangxin capsules led to a significantly greater reduction than did the?placebo (240.15 pg/ml [Q1, Q3: 23.15, 1,113.85]) vs. 0.00 pg/ml [Q1, Q3: 286.00, 800.00]; p?= 0.002). The mean percent reductions in NT-proBNP level for the qili?qiangxin capsule and placebo groups were 24.70% (Q1,?Q3: 1.55%, 63.70%) and 0.00% (Q1, Q3: 18.08%, 43.79%) (p?< 0.001), respectively. A total of 47.95% of the patients in the qili qiangxin capsule group had reductions in NT-proBNP levels of at least 30%, compared with 31.98% of patients in the placebo group (p?<?0.001). Table?3 presents the rates of CCEs for both groups. Overall, 4.</div>

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