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Lithium was inferior to placebo in leading to drop-outs for reasons other than a mood episode (random effects RR 1.33, 95% CI 1.07 to 1.65) but superior to placebo on study completion (random effects RR 1.69, 95% CI 1.12 to 2.55).
Mortality at ICU discharge did not differ between the treatment and the control group, as well as ventilator free days evaluated after 28 days from admission and length of ICU stay among survivors (Additional file 1 Table 1, reporting patients' outcomes on study completion).
Individualised reports were provided to participants on study completion.
We report on study completion in all 30 who had commenced post-treatment assessments.
Data are collected at baseline and on study completion at two years.
Telephone interviews were conducted to followup on missing/incomplete diaries and on study completion.
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This choice does not reduce the validity of our conclusions less valid; rather, it allows comparisons conditional on study completions.
Post hoc (and postrandomization) assessments were conducted to establish whether treatment effects on A1C and weight were consistent among subgroups on the basis of study completion status (ITT population or 84-week completers) and oral blood glucose lowering medication use (metformin alone).
This law mandates the posting of defined clinical data items on registries within a year of study completion.
In the oral HIP group, in addition to the 6 patients who were on an ESA at study entry, one more patient was started on ESA by study completion.
Blood and urine samples were collected within 14 days prior to inclusion (pre-inclusion screening visit) and on visit 3 (study completion, day 28 ± 2).
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