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Behavioral, cognitive, and mood variables described below were assessed at times 1 and 2 by self-report questionnaires.
All parameters described below were assessed at randomization and after one year of treatment by medical staff, unaware of the type of treatment.
Depression and anxiety were assessed pretreatment, appraisals were assessed posttreatment, and all other psychological predictors described below were assessed at every measurement occasion.
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Background information (such as education and language skills, see below) was assessed at baseline.
Outcome measurements (see below) are assessed at baseline (before start VLCD), and again at 4 months (after VLCD and 10 CPI sessions), 1 year, 1 ½ years and 2 years.
The response category (see below) was assessed at least once daily during hospitalization and during return visits that were scheduled 4 and 10 weeks after the start of therapy.
All the experimental procedures outlined below were assessed and approved by an animal ethics committee at the University of Western Australia (07/100/607).
All measurements detailed below are assessed both at baseline and following the intervention at one year so that changes during the trial may be computed.
Recovery of simvastatin and of simavastatin hydroxy acid from mouse plasma following the extraction procedure below, was assessed by comparison of samples at three doses (30, 80 and 150 ng), which were used to spike 0.1 ml mouse plasma followed by extraction and injection into LC-MS, to similar doses directly injected to the LC-MS.
At six and 12 months postpartum their mental state (see below) was assessed.
Participants were assessed at baseline with the measures outlined below.
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