b. Analysis Plan - Initially, we will present descriptive statistics (mean, standard deviation, range) for all endpoints to treatment and placebo groups. We will also present graphical plots of all measures across the study and for each group within each period. For the 2x2 crossover study, we will compare the treatment and control on each endpoint separately by employing a generalized mixed model approach with the predictors: group(sequence), patient nested within group as a random effect, period(dichotomous), treatment(dichotomous), and seasonality(dichotomous), with unstructured covariance. We will utilize mixed model diagnostics such as residual plots to assess goodness of fit.