The randomized crossover trial (Phase 1) is supported by an ancillary trial (Phase 2) of longitudinal-observational design to assess the longer term effectiveness of sodium restriction.
In the ACCORD trial, for which referred participants were felt to be capable of adhering to a very complex protocol, 20% of those in the ancillary trial of cognition were found to have undiagnosed cognitive dysfunction at baseline (J. Williamson, personal communication) (60).
MM, FS, PdeC, BA designed the clinical trial and ancillary biological trial.
First, an obvious methodological limitation was the lack of a control group, which was not possible in this ancillary open trial.
Ancillary analyses of trials were not included if the original study reported mortality outcomes for the whole population.
BP trajectories have been reported in longitudinal studies of children (1, 2), but trajectories in adults with diabetes are usually ancillary to treatment trials for hypertension, and the results are explained in terms of the assigned medication (3, 4).
We have evaluated the production of antibodies directed to respiratory and systemic pathogens in a group of elderly COPD patients, recruited in a clinical trial, ancillary to a larger multicenter double blind, placebo-controlled, parallel-designed clinical trial in which patients were randomized to daily receive either PMBL or placebo.
Item 30: Provisions, if any, for ancillary and post-trial care and for compensation to those who suffer harm from trial participation "Patients that are enrolled into the study are covered by indemnity for negligent harm through the standard NHS [National Health Service] Indemnity arrangements.
Participants will be provided with ancillary and post-trial care for any injury sustained as a result of their involvement in the trial.
No additional ancillary or post-trial care will be provided beyond the usual care covered by the Quebec provincial healthcare plan.
