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Alternative plans should be considered and be available for continuation of the study under new circumstances.
Thus, we can conclude that CAL is sufficiently safe for continuation of the study, though controlled investigations and accumulated long-term results are needed to elucidate the overall safety and efficacy of the treatment.
The responsibilities of the DSMB are to monitor safety data on a regular basis and, if required, on ad hoc basis to guide recommendation for continuation of the study or early termination because of clear harm.
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Based on these data, the conditions of 15 μmol/L genistein and 3 Gy photon radiation were selected for continuation of the studies.
An independent data monitoring committee conducted an end-of-phase II analysis of data from the HORIZON programme, which showed that cediranib 20 mg day−1 met all of the predefined criteria for continuation of the HORIZON II study; all subsequent patients were randomised 2 : 1 to the cediranib 20 mg or placebo treatment arms.
Therefore, this dose was selected for the continuation of the study.
This approach did not influence the conduct of the trial, since the immunological efficacy of the vaccine was not critical for the continuation of the study.
Another centre did not receive the clearance from the Ethics Committee for the continuation of the study in time; hence further nine patients were not eligible for participation.
For the continuation of the study we decided to characterize in better depth only the most active, 343 bp long CNS87, located 84.6 kb upstream of the Pax8 5'UTR.
One of these studies suggested that the main provocative factor for continuation of the practice is tradition and customs inherited in the family from mothers to daughters [ 8].
Thus, the new classification had proven to be useful tool for continuation of genome study, while annotated TR can be the valuable source of cytogenetic probes for chromosome recognition.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com