Suggestions(2)
Exact(4)
Subsequent design changes for this main trial were informed by ZM.
Before starting this main trial, we conducted a pilot study, Vasopressin and Corticosteroids in Septic Shock (VACS).
Nested within this main trial was a second study of umbilical cord care where within each skin care group (0.25% chlorhexidine or placebo) infants were randomized to receive either 4% chlorhexidine, soap/water, or dry cord care only [ 13].
The extensive quantitative and qualitative work in our pilot trial has indicated that the planned intervention is effective and acceptable, and our process evaluation in this main trial will focus on (i) mechanisms of change and differential response in patient subgroups, and (ii) the process of implementation of the intervention [ 35].
Similar(56)
Covariates known to be associated with the incidence of malaria in this population from the main trial were then added to the models (ownership of an insecticide treated net, rural residence and distance of residence from the nearest health facility).
27 This protocol describes the main trial that compares vasopressin to noradrenaline as initial vasopressor in the management of adult septic shock.
We believe that this result of the MAIN trial does not necessarily have to lead to the conclusion that bevacizumab is ineffective in DLBCL.
It would have been preferable for this information to have been gathered before the main trial, but this was not possible due to time restrictions.
Given that so much of this endeavour occurred at the main trial stage, we mainly identified learning for future trials.
We appreciate the interest of family members and patients in research, which enabled the main trial and this study.
Human research ethics approval for both the main trial and this study were obtained from The University of Newcastle and The Cancer Council Victoria, and registered with the Australian and New Zealand Clinical Trials Registry, registration number ACTRN12609000628246.
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