The all-control population consisted of all patients randomly assigned in the five core studies; data from the double-blind periods were collected from randomization until the first change in treatment regimen or until 2 years of treatment.
For instance, there was a minimum 28-day period from screen to randomization.
The patient follow-up has three distinct phases--from randomization and baseline injection to the primary endpoint at six weeks, from optional crossover at six weeks until nine weeks, and the follow-up period from nine weeks to one year after randomization (see Figure 1).
Variation in the Ca × P product during the maintenance period from baseline (time of randomization) is shown in Table 4.
Patients who were receiving beta-blockers or ivabradine entered a 2-week washout period from these drugs before randomization.
The primary endpoint was RFS, considered as the time period from the date of randomization to the date of first detection of recurrence or death, whichever occurred first.
Early responders and early nonresponders maintained on risperidone were compared for health-state utilities (benefits) and total cost over the 12-week study; early nonresponders maintained on risperidone or switched to olanzapine were compared from randomization (10-week period).
Of note 299 patients were not able to provide two HbA1c measurements in a two month run in period post randomization, and were removed from the study.
The primary endpoint of the study will be the number of CD8+ cells (cell counts per mm) in bronchial biopsy tissue specimens (sub-mucosa) evaluated from randomization to the end of the intervention period.
Each patient's QALY was then calculated, from randomization to death or censoring date, by multiplying the duration of each period by the corresponding period's utility score.
