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The main efficacy outcome in our study (symptomatic venous thromboembolism) was a secondary outcome in all studies.
The Beck Depression Inventory total score at the end of the study will constitute the main efficacy outcome.
The main efficacy outcome and secondary outcomes were measured at baseline, 12 and 24 weeks, except for the blood parameters that were assessed at baseline and 24 weeks.
Evidence for treatment differences in the main efficacy outcome measures will not be monitored through review of accumulating outcome data and no interim data analyses will be conducted.
The main efficacy outcome of the study is rate of PrU-II healing or ulcer epithelialization tissue (scored on the PUSH scales as 0).
The main efficacy outcome was an overall response that integrated clinical, bacteriological and radiological results, at the end of treatment (month 6) and after 12 additional months of follow-up (month 18).
Similar(53)
Fig. 2 Main efficacy outcomes.
#Particularly regarding safety-whether it included adverse events and/or main efficacy outcomes.
The main efficacy outcomes in EPHESUS were patient-oriented, measuring mortality and/or hospitalization.
Main efficacy outcomes included vision maintenance and best-corrected visual acuity (BCVA) at week 52.
Three main efficacy outcomes and three harm outcomes were therefore sought from the trials, using the denominator of the number of patients randomised so that results were on an intention-to-treat basis.
Related(14)
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