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Due to major study protocol violations, 8 patients needed to be excluded for various reasons, which led to a final number of 51 cases receiving navigated HTO recruited in six centers between January 2006 and October 2007.
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An assessment of efficacy (according to RECIST criteria) was conducted in patients who received at least one treatment cycle, had at least one follow-up tumour assessment and had no major on-study protocol deviations.
No major deviation from the study protocol was apparent.
There were no major changes in the study protocol after initiation of the study.
No major deviation from the study protocol occurred.> The age range of the sample was 28 to 80 (53.63 ± 12.91).
That said, there were no international reports of major problems with the study protocol or draft versions of instruments reported to the study team.
This definition was selected to be consistent with the "REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study" protocol [ 9].
To verify patient compliance with the treatment management, private physiotherapists participating in the study, general practitioners and institutional therapists report any major difference from the study protocol to the investigators of the study.
The process of stakeholder involvement resulted in major modifications to the study protocol, including: a) important changes to the questionnaire; b) addition of the Midland plume area as a separate study group; and c) addition of Jackson and Calhoun counties as control areas.
The prospective study is the third major study under the Treatment Improvement Protocols (TIPs) evaluation project, which uses diffusion of innovations theory as its theoretical framework.
This major study was approved by the Research Ethics Committee (protocol nos. 748-11 and 921-12).
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