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These two patients who did not meet the inclusion criteria were registered as screening failures.
The four patients identified as screening failures initially seemed to be eligible for the study by the investigator.
Similar(58)
Out of 72 patients, 14 were excluded for reasons such as screening failure (n=7) and dropout (n=7), and 58 were included in the final analyses.
A subtlety of this analysis is that breasts characterized as 3 were treated as screen failures (MBI negative as a test result with a binary decision).
Of these, 28 patients were excluded as screen failures because of inadequate SF samples.
The latter patient had a history of diabetes prior to randomization and was listed as a screening failure.
A patient who had been assigned a patient identifier and had completed at least one study procedure (in addition to signing a consent form) but had not met inclusion or randomisation criteria to enter the treatment period or who did meet the exclusion criteria was classified as a screening failure.
Two of the screened patients were screening failures and 33 were nonevaluable as a result of insufficient data available for the study.
Two screening failures were noted.
Five patients were screening failures.
There were 27 screening failures.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com