One postsurgical study was a multiple dose trial for which information for the first dose was available over 12 hours.
One study consisted of a multiple dose trial in which the authors provided additional data for the four trial arms (200, 400, 600, and 800 international units (IU) D2 v placebo).w1 Falls were defined as "a sudden, unintentional change in position causing a resident to fall on the ground".
In the multiple dose trials, all women received each treatment regimen for one cycle.
We have addressed this by combining the multiple dose trials in one analysis, using the longest follow-up time point.
We presented the primary outcomes for the review in the 'Summary of findings' tables, and added height, school attendance, and death for multiple dose trials.
In the other two multiple dose trials, the proportion of patients reporting any adverse effect was 23% (42/179) with rofecoxib 50 mg, 24% (45/181) with naproxen sodium 550 mg, and 18% (33/178) with placebo.
For the multiple-dose trial phase entry criteria included measurable tumors of greater than 3 cm in the longest diameter.
A Phase I multiple-dose trial studied the pharmacokinetics, pharmacodynamics and safety of BAF312 in 48 healthy subjects.
Cohen and colleagues report a randomised, placebo-controlled, multiple-dose trial using a monoclonal antibody blocking IL-1 type 1 receptor.
This phase IIa, multicentre, randomized, placebo-controlled multiple-dose trial assessed the safety and tolerability of sotatercept at multiple dose-levels, and determined the effect of the drug on bone remodelling in MM patients with osteolytic lesions (ClinicalTrials.gov identifier: NCT00747123).
A recent 24-week, open-label, phase Ib, parallel-arm, multiple-dose trial in 41 subjects with schizophrenia demonstrated that the once-monthly LAI formulation at doses of 300 and 400 mg provided sustained mean aripiprazole plasma concentrations comparable with the concentration range observed with the corresponding dose of the oral formulation.
