Detailed study inclusion and exclusion criteria are given in table 1 and 2. Patients are randomized at a one to one ratio to sirolimus or standard treatment alone.
Two patients were randomized at more than one trial center but only data from the trial center in which they were first randomized were included in statistical analyses.
Subjects were randomized at the cluster level to one of two groups: training group 1 (TG1, n = 282) performing supervised strength training from February to June 2009 (round one) or training group 2 (TG2, n = 255) performing supervised strength training from August to December 2009 (round two).
The early non-responder ITT population was defined as all subjects who were randomized at Week two, received at least one dose of study medication after the randomization at Week two, and had both a Week two efficacy assessment and at least one efficacy assessment after Week two.
One cluster RCT was randomized at clinic [ 18], and the remaining four trials were randomized at a patient level [ 14- 17].
METHODS: A sample of African American patients with diabetes (N = 400) will receive written education material at baseline and be randomized to one of 2 arms: (1) usual primary care or (2) nurse-administered disease-management intervention combining patient self-management support and provider medication management.
Participants (n = 80) at two study locations will be randomized into one of two groups.
As per protocol, the FAS, following an intent-to-treat principle, consisted of all patients who were randomized, had at least one randomized study drug intake, and had an evaluable baseline and at least one evaluable post-baseline SCr measurement.
The test will be performed in the intention-to-treat (ITT) population consisting of all patients randomized with at least one report on antibiotic use.
The secondary outcome was cumulative live birth following a fresh and one or more frozen cycles, i.e. the proportion of couples randomized with at least one live birth.
