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Patient populations and reasons for discontinuation. Patients were excluded from the PPS for major protocol violations; the rate of exclusion ranged from 13.6% to 22.2% across arms. The most commonly reported protocol violation was a deviation of the initial dose of study drug that was either greater than or less than 10% of the recommended dose. Bas, basiliximab; FAS, full anaysis set; PPS, per protocol set; SAF, safety set.
