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The number of patients enrolled, eligible, treated, and followed at specific visits is reported. Follow-up evaluation time points were adhered to ��?2?weeks. The exclusions from the per-protocol population are also displayed together with the reasons for exclusion. The timing and reasons for study withdrawal are also displayed inclusive of aborted procedure, adverse event precluding follow-up, subject decision, and investigator decision. The mild and traditional injection therapy groups were analyzed separately for safety and effectiveness and selleck kinase inhibitor the 2 groups compared. As the intent of this study is to compare the effectiveness of mild and traditional injection therapy, a 95% confidence interval of the difference (��) in the percent of subjects in each group to achieve improvement Azastene in VAS or increased mobility in ODI was calculated. The limits produced by the 95% confidence interval of the difference (��) between the 2 therapies indicate the smallest and largest differences that can be expected with repeated testing in this study population. Patients in this study were treated at a single pain management center from September 2009 to January 2011. A total of 38 patients were randomized into the 2 treatment groups, with 21 patients in the mild group and 17 patients in the ESI group (Figure?1). As patients were sequentially randomized and assigned randomization numbers were not replaced in the event a patient was randomized but not treated, the number of patients in each treatment group is not precisely the same. Of 50 VE-821 supplier patients screened for potential enrollment in the study, 12 patients were excluded. Of these, 4 patients did not meet the study inclusion/exclusion criteria, 3 declined to participate, 4 were advised not to participate by the investigator because of significant comorbidities, and 1 patient was screened but not treated prior to study closure. Mean age in the mild group was slightly lower at 74.2?years (range 51 to 89), compared with 78.7?years (range 64 to 89) in the ESI group. Only 1 patient in the study was
