Patient recruitment began in December 2004 at three clinical sites in Missouri and the final follow-up was conducted in January 2006. A total of 67 subjects were enrolled in the trial and underwent randomization (see Fig. 1). Of these subjects, 61.1% were from site 1, 29.9% from site 2, and 9.0% from site 3. In terms of OA functional grades, 20.9% were grade I, 28.4% were grade II, 20.9% were grade III, and 29.9% were unassigned. Seven subjects did not complete baseline evaluations, resulting in a total of 60 subjects in the intent-to-treat (ITT) population. Thirty-one subjects (51.6%) were randomized to the placebo group and 29 subjects (48.3%) were randomized to the NEM® treatment group. Thirty-one percent (31%) of the ITT subjects assigned to NEM® did not complete the 2-month study per the protocol, compared with 42% of the ITT subjects assigned to placebo. Of the 60 subjects in the ITT population, six subjects assigned to placebo and two subjects assigned to NEM® either violated the protocol or did not begin treatment and, therefore, were not available for further analysis. Those patients lost to follow-up before the first evaluation time point in both the placebo (four patients) and treatment (three patients) groups had symptomatically mild OA (mean WOMAC 39.7 and 45.6, respectively). Those patients lost to follow-up (primarily withdrawals) in the remainder of the study in both the placebo (three patients) and the treatment (four patients) groups had symptomatically more severe OA (mean WOMAC 76.6 and 63.7, respectively) compared to those patients that completed the study (mean WOMAC at baseline of 52.6 and 45.3, respectively). Five patients in the placebo group and four patients in the treatment group officially withdrew from the study due to lack of efficacy. There were no obvious differences in the reason for withdrawal between the study groups. The overall drop-out rate of 43% (from enrollment) was considerably higher than the estimated rate of 20%, although >70% of the subjects that began treatment (n = 54) completed the study (excluding non-compliance). This is possibly related to the small sample population or could also be due to the relatively stringent pain management requirements of the study protocol. Compliance with the study treatment regimen was good in both treatment groups. In those subjects that completed the study, the rate of compliance was >97% (as judged by capsule count at clinic visits).