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Endpoints were assessed at enrolment (screening visit: −1-month −1-monthin the week before randomization (baseline, 0-month visit) and on the last treatment day (end of treatment: 12-month vinithe
Outcomes were assessed at enrolment (screening period: −4.5 and −4 months visits), at baseline (0 month visit), and on the last day of treatment (12 month visit).
Thus, this subcohort represented a mixture of higher risk women (based on enrolment screening results and sexual behaviour) and was supplemented by a random sample of the remaining cohort population.
Clinical assessments were performed 14 days before enrolment (screening visit), and follow-up visits at one month and one year after the infusion.
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A pre-enrolment screening questionnaire was used to record the history regarding the patients' complaints.
A pre-enrolment screening questionnaire was used to record the social and medical history of the patients and no differences were observed.
22 All studies reviewed had pre-enrolment screening and some level of physical examination and laboratory tests to exclude individuals at risk for adverse cardiovascular or orthopaedic outcomes during the trial.
Samples collected at patient enrolment were screened for SNPs at dhfr c108, c59 and c51, using PCR-SSOP as previously described [25], [35] and provided an estimate of baseline allele frequencies at this locus.
After screening, enrolment and baseline examinations will be performed.
21 22 After screening, enrolment and baseline assessment, participants were randomised by computer to the following arms: WHC (Experimental), Nutrition (Attention-Control) or HCT-only control.
Enrolment and screening will be undertaken via the internet.
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