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In this other trial, parents who were randomly assigned to receive exactly the same intervention for discipline issues demonstrated improvement in both children's behaviour and parenting.
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However, this study was also the only trial to specifically select participants with psychological symptoms, and thus a greater proportion of this than the other trial groups had a need for professional help [ 55, 56].
In three studies there were no statistically significant differences in EQ-5D between treatment groups and this agreed with the other trial outcomes [ 17, 18, 22].
In one trial participants completed 2 × 30 s WAnT tests (WAnT1 and WAnT2) with a 6 min recovery period; in the other trial, this protocol was preceded with 4 sets of biceps curls to induce localised arm fatigue.
But how this and the other trials will proceed is far less predictable.
In the other trials this event was reported to be similar in both the microbicide and placebo arms.
In one trial (the MA 17 trial), the OS advantage was seen in a planned subgroup analysis (Goss et al, 2005), but in the other trials this was a prospectively predefined end point seen in the entire study population.
The majority of the other trials in this area have focussed on changes to markers of inflammation and the lipid profile with varying results [ 17– 19, 21, 22].
This, together with other trial evidence (Ascierto et al, 2006), points to there being no routine role for low-dose therapy within this patient group.
Web extra appendix 3 summarises considerations that need to be taken into account when applying the methods described in this paper to other trial datasets.
In any other trial, this might not be a remarkable thing to say.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com