The base 10 log distributions of E. coli colony forming units (CFUs) per two hands were categorized into four levels (< 1, 1 2, 2 3, and 3 4) and displayed graphically to show the variability in concentration within each study arm as well as between the study arms.
The PSAs were conducted as Monte Carlo simulations with 10,000 iterations using the @Risk software (Palisade Corporation, Ithaca, NY) and the distributions displayed in Table 4 to calculate costs and effects for a reference population of 1,000 individuals in each study arm as well as ICERs of introducing RDTs instead of the current diagnostic techniques.
Originally, we proposed to recruit the sample by placing mobile units in selected "hotspots" for both study arms to serve as recruitment venues.
According to French law, since the strategies used in both study arms are classified as standard care, no specific reporting procedure for unexpected serious adverse events is planned.
However, as actually administered therapy depends on various factors (e.g. patients' comorbidities, development of toxicities) and may change over time due to emerging evidence, the administered systemic therapy is documented carefully for each patient in both study arms and is considered as a covariate in multivariate analysis (in addition to centre as factor in multivariate analysis).
The Phase 1 intervention is a low-moderate intensity (i.e. one contact per week) community-based group lifestyle program that is delivered identically to both study arms and therefore is evaluated as a pre-post study in the present paper.
After implantation of a catheter patients will be treated as follows: Both study arms receive a chemotherapy consisting of 2000 mg/m/day 5-FU by IV (24 hours) 200 mg/m/day FA IV (30 min) on day 1, 8, 15 and 22 together with 85 mg/m/day oxaliplatin IV (2 hour) on day 8 and 22. Therapy will be interrupted between days 23 to 42.
As previously reported, both study arms showed similar patterns of change in BMI and waist circumference during the trial (9).
Identical β-lactams did not need to be administered for both study arms in a particular trial, so long as both drugs were β-lactam antibiotics with similar spectrums of activity.
