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Betamethasone valerate vs dipropionate -amoxicillin-clavulanate was used to assess treatment outcomes using the Kaplan-Meier method, assuming survival of 1 year. Multivariable-adjusted mortality was based on multivariate Cox Models. The results of regression analysis were summarized using the log-rank method. results of multivariate Cox Models for age group (50–84 years [reference], ≥85 [carcinogen]), sex, treatment group and duration of follow-up were analysed by using Stata version 8.0. All-cause mortality was the primary outcome, with analysis adjusted for study site, treatment group (Cipro XR vs Cipro/Vibramycin), follow-up period (2 and 5 years). The results of Cox regression models were analyzed by using the unmodified Poisson generalized estimating equation, a Cox regression procedure where fixed effect model is specified, with all covariates specified as in a fully adjusted model (28). Results Baseline Characteristics The study was reviewed and declared compliant with the ethics statement as described by the European Committee for Clinical Trials, which states in part: "The institutional review boards (IRBs) in the UK (ClinicalTrials.gov number)" and US (Expertrials.gov number) approved all relevant procedures. A total of 1255 participants were screened as part of the trial in 4 clinical centres of the Oxford-Worcester cluster: Oxford (CIPRO), Coventry Birmingham and London (Cipro/Vibramycin). The study had a total enrollment of 3199 participants, including a total of 1115 Cipro/Vibramycin patients. Of the 1191 eligible participants (Table 1), 1120 (73%) agreed to participate, the remaining 612 were declined, and the last study enrollee died on October 27, 2009; therefore, 1120 participants were enrolled (Table 1). Table 1. Characteristics of All CIPRO/Vibramycin/Uncertain Cipro/Vibramycin Participants at Baseline Figure 1 presents the mean age of enrolled participants, with (years) and median plasma concentrations (μg/mL) of levonorgestrel and the mean concentrations of study treatment groups (Cipro XR [Cox 2], Cipro XS [Clara]) and the mean Cipro XR Cipro/Vibramycin plasma levonorgestrel concentrations for all study participants by follow-up (Figure 1). The median plasma concentrations were significantly and inversely associated with age after correcting for (Table 1, Figures 2 through 4). Figure 1. View largeDownload slide Mean and median plasma concentrations of levonorgestrel and the mean concentration in CIPRO/Vibramycin, Cipro XS and Cipro/Vibramycin by follow-up (n=1191, data are the mean ± standard error). Figure 2 (Figure 3) presents the Kaplan-Meier survival curves. A statistically significant benefit was observed with a hazard ratio of 0.73 (95% confidence interval 0.61–0.98) compared with the levonorgestrel concentration in Cipro XR treatment group and a hazard ratio of 0.84 (95% confidence interval0.72–0.99) compared with the Cipro/Vibramycin concentration. Similarly, no evidence for statistical heterogeneity was found in the multivariate-adjusted Cox analysis, with an analysis of covariance model including the median plasma concentrations and other covariates as in a fully adjusted model indicating slight excess mortality in the Cipro/Vibramycin group (hazard ratio of 0.87, 95% confidence interval 0.80 to 1.00, P = 0.07) (Figure 3, Figure 3C). In the multivariate-adjusted Cox analysis, a survival benefit was also found with the levonorgestrel concentration for those using the Vibramycin (hazard ratio of 0.74 [95% confidence interval 0.61–0.96], P<0.01). Figure 2. View largeDownload slide Survival curves for all CIPRO/Vibramycin