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Sensitivity analyses were performed to assess the impact of missing data, important protocol violations, and premature discontinuation of trial medication on the primary endpoint.
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Crossovers that occur at the time of surgery are another important protocol violation.
We identified 15 protocol violations involving 15 participants.
Significant protocol violation or non-compliance.
There were 51 protocol violations.
There were 51 protocol violations for 49 patients (Table 2).
Five patients were excluded due to protocol violations.
There were a total of 96 major protocol violations.
No major protocol violations occurred.
There were no protocol violations.
There were three protocol violations.
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