There were no missing data in respect of the primary endpoints of the study.
The principal endpoints of the study were the LOS and the 1 year mortality after an SCIC admission.
The primary endpoints of the study were investigator-assessed safety in all treated patients (the safety population), the maximum tolerated dose, and the pharmacokinetics of umbralisib.
The primary efficacy endpoints of the study were time to absolute neutrophil count >500/μl and platelet count >20,000/μl.
The primary endpoints of the study were to determine the 1) intra-observer, 2) inter-observer, 3) day-to-day, and 4) side-to-side variations of the circumference of the MCA and the MMA.
Endpoints of the study were: 1. MRTI T2 signal differences between loaded and unloaded FSUs. 2. Morphometric analyzation of unstained area in the endplate and the growth zone of loaded and unloaded FSUs.
From the overall picture of the publication, it can be concluded that the comparisons of "ibuprofen 400 mg versus placebo", "diclofenac potassium 12.5 mg versus placebo" and "diclofenac potassium 25 mg versus placebo" should constitute the primary endpoints of the study and the comparisons between the verum treatments the secondary endpoints.
The DSMC advised the Principal Investigators in this study to stop recruitment to the trial based on a priori defined difference (p<0.01) between the two treatment arms in the primary endpoints of the study.
Before the recommended sample size had been reached, once 169 blood culture positive patients had been enrolled, the independent data safety monitoring committee (DSMC) advised the Principal Investigators to stop recruitment to the trial based on a priori defined difference (p<0.01) between the two treatment arms in the primary endpoints of the study.
The primary endpoints of the study were as follows: for safety, the proportion of subjects with diarrheal adverse events during the study period and for immunogenicity, the proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies relative to baseline, 14 days after the second dose of either the killed oral cholera vaccine or placebo.
The endpoints of the study were major infections.
