The early randomization at day 0 also might have affected baseline values and treatment outcomes.
At the time of enrolment, before starting TNFα blockers, all study patients were receiving treatment with traditional DMARDs, which might have affected baseline PASI scores.
19 50 We previously showed that such a low response rate might affect prevalence estimates of baseline characteristics of participants but does not cause bias in the examined associations.
To avoid the possibility that undergoing baseline assessments might affect outcomes, only a random sub-sample (∼25%) of UC patients were seen at baseline and then all UC patients were invited for assessment at 1 year.
Considering that the preference for a specific mood stabilizer (lithium, valproate, or a combination of the two) given a specific baseline condition might affect the results of the main analyses, we compared demographic and clinical variables among the three groups divided by medication type (Additional file 1: Tables S4, S5).
Because of our small sample size and the possibility that randomization may result in unequal groups, we measured several factors at baseline that might affect patients' decision making.
Second, the lipid profiles and blood pressure between the RAMP-DM and usual care groups were not well matched at baseline, which might affect the changes over 12 months.
To make an unbiased estimate of the confounders, propensity score method was used to adjust baseline characteristics which might affect dialysis withdrawal and subsequent patient outcomes.
We excluded women with previous myocardial infarction, stroke, or coronary revascularisation at baseline, and those reporting current use of β blockers, digoxin, or non-dihydropyridine calcium channel blockers at baseline, since these agents might affect heart rate.
