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(I.11) Other participants were in contrast more ambivalent about the trial, participating on the basis of no harm rather than in pursuit of direct benefit (I.1,6,9).
According to the experience in previous trial, participating in a study like this is unlikely to be burdensome for patients [ 18, 4, 35, 36].
In keeping with the pragmatic orientation of the trial, participating physiotherapists will not be prevented from administering stretches or manual therapy.
The unit costs of clinical events that are unique to this trial will be derived from the hospital accounts of the trial participating centres, although primary research that uses established accounting methods may also be required.
For the main trial, participating GP practices used their lists to identify all eligible males and females, (aged ≥18 years with a body mass index [BMI] >28 kg/m) and sent them invitations to participate.
Multi-centre cluster-randomized clinical trial: participating professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12 months, and a follow-up of 6 months (total 18 months).
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All participants who entered the trial participated until the end.
Participant characteristics: Sixteen participants from the intervention arm of the HIVIND trial participated in this study.
Results: A total of 230 women (115 in each arm of the trial) participated in the study.
A subset of the patients recruited by the UK centres in the IST trial participated in a study of quality of life after stroke.
Jean-Yves Genot conducted patient trial, participated in patient enrollment and manuscript review.
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