Study visits took place three times before randomization, at randomization, and at 4 weeks and every 6 months after randomization until the date of death, censoring, or end of the study in March 2004.
All outcome measurements will be collected 3 times: before randomization, upon the graduation from the program (6 months after the program start); and at the end of the follow-up period (18 months after randomization).
In these studies, included patients had been on the baseline treatment for a time period before randomization (eg. ERA for at least 4 months prior to randomization [ 42] which was assumed sufficient to derive maximal benefit from the baseline treatment.
Data collection takes place at three time points: baseline (before randomization), 12 months, and 24 months.
A corticotropin test was performed at the time of randomization, before the administration of the treatment dose.
Health-related quality of life questionnaires will be administered at the time of randomization (before patients are aware of their treatment allocation), at baseline (i.e. month 0), and at three and six months of the study.
The waiting list group was assessed at four times: at baseline (before randomization), after waiting 6 months for CBTp, at post-treatment (12 months after baseline), and at follow-up (12 months after therapy).
In contrast to the SWITCHMRK study population, the median time of viral suppression before randomization in the SPIRAL study was 73 months.
The outcome assessments will be performed by an independent evaluator who is blinded to the treatment allocation at three time points: baseline (T0, before randomization), two weeks after the intervention/TAU (T1, primary endpoint), and six months after the intervention/TAU (T2, follow-up).
All outcomes will be assessed for a three-month period at three time points: at baseline (before randomization), after the end of the intervention, and the primary outcomes one year after the end of the intervention to measure the long term effects of the intervention.
Arterial blood samples were collected at three specific times: on randomization before fluid administration, 6 and 24 hours after initial resuscitation.
