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Crossovers that occur at the time of surgery are another important protocol violation.
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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.
Significant protocol violation or non-compliance.
This single patient received ASCT (protocol violation).
Protocol violation.
No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported.
Protocol violations will be recorded; data will be analyzed with and without patients with protocol violation.
This will be recorded as a minor protocol violation.
Compliance < 70% was considered a major protocol violation.
Protocol violation was more common in the control group.
One participant was excluded because of protocol violation.
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