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The present study was approved by the data safety officer and the Ethics Committee (082-08) of the medical faculty of the Ludwig-Maximilians-University Munich and the Bavarian Ministry for Teaching and Culture.
The study was stopped prematurely by the data safety monitoring board for ethical reasons.
A simple randomisation list without blocking was computer generated and held by the data safety and monitoring board only.
An interim analysis was conducted by the data safety and monitoring board at the midpoint of the data collection period.
All adverse events within 180 days after study inclusion are monitored and continuously evaluated by the data safety and monitoring board.
However, the planned interim analysis by the data safety and monitoring board indicated that the primary and secondary efficacy endpoints would not be met.
Similar(42)
The decision to end the study came on May 31, in a periodic look at its accumulating data by an expert panel, the data safety and monitoring board.
18 Further follow-up for birth defect cases was conducted if additional information was needed by the dysmorphologist or the data safety monitoring board (DSMB).
SUSAR's will be analyzed by both the SCC and the data safety monitoring committee (DSMC).
This is, to a large extent, a consequence of the U.S. chemicals market, which has been shaped over the last 30 years by the combined effects of the data, safety, and technology gaps.
The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com