Analysis of the primary endpoint, change in albumin excretion, will be undertaken on an 'intention to treat' basis.
An accredited 6-week psychological life skills program 'FRIENDS for Life', which is designed to provide behaviour change and coping skills will be undertaken prior to volunteers being randomised to group.
Analyses of the change in this continuous measure will be undertaken on an intention-to-treat basis, including all participants randomised regardless of treatment actually received or withdrawal from the study.
Separate analyses will be undertaken using acute changes in SPECT signal (< 12 week images) as well as the long-term changes indicated by images taken at 52 or 78 weeks post-radiotherapy.
Additional analyses will be undertaken to assess changes in the secondary objectives and to assess the overall effect of the intervention on quality of life and health economics.
Under the changes, 51-75% of Fera's science work will be undertaken by the proposed joint venture.
Direct observations of practice in multiple sites will be undertaken to identify work role changes and innovation.
An immediate post-intervention assessment will be undertaken six months post-intervention to evaluate changes in quality of care.
However, since questions are often raised about the long-term maintenance of changes in physical activity 29 30 a 12-month follow-up survey will be undertaken.
Final analyses will be undertaken using generalized linear mixed models to investigate changes over time in the two groups in the major outcomes.
More data on the frequency of QTc changes will be known following phase II trials where monitoring during cycle 1 will be undertaken.
