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This innovative trial will recruit 300 participants across central Illinois who will be randomized into the intervention arm or control arm of the study.
An ongoing trial in Guinea with the VSV vaccine found that it protected participants so well that the control arm of the study was abandoned after an interim analysis.
This trial will recruit 30 persons with MS across central Illinois who have an Expanded Disability Status Scale score between 4.0 and 6.0, and those persons will be randomized into either the intervention or control arm of the study; the participants will not be blinded regarding group assignment.
Participants assigned to the control arm of the study received standard care and those assigned to the intervention arm received a program of lifestyle modification including structured exercise training sessions and diet counselling.
Participating clinics will be randomly allocated to either the intervention or control arm of the study.
Coaches allocated into the control arm of the study were asked to coach as usual.
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Third, there was no randomization of facilities to intervention or control arms of the study.
Five hospitals were each randomized to the intervention or control arms of the study.
Fieldworkers will be blinded to the allocation of schools to the intervention and control arms of the study.
We found a significant difference in the secondary outcome between women in the intervention and control arms of the study.
Baseline comparison of women randomized to intervention and control arms of the study are presented in Table 2.
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