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Protocol violation.
Indications for antibiotic therapy Adverse reactions to the study drug Protocol violation.
Releasing the data without an approved modification would be a protocol violation.
Of the 77 patients, 11 prematurely withdrew for administrative reasons (noncompliance, consent withdrawn, loss to follow-up, protocol violation).
Withdrawal criteria were withdrawal of consent, appearance of other species of Plasmodium or major protocol violation.
Ten (5.0%) were either lost to follow-up (9) or withdrawn owing to protocol violation (1).
Significant protocol violation or non-compliance.
Protocol violation was more common in the control group.
One participant was excluded because of protocol violation.
Non-compliance with medication, protocol violation or unreliable behaviour.
This will be recorded as a minor protocol violation.
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