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Clinical Trial Dosing Ranges Dose Titration Schedules Clinical trials have employed gradual dose escalation to minimize gastrointestinal side effects [9] : Standard Titration Protocol (Example from ONWARDS 1) Rationale: Gradual titration allows tolerance development to gastrointestinal effects (particularly nausea) while building up to therapeutic doses

The gastrointestinal-protection profile motivated the Pliva clinical development program (PL-10, PLD-116, PL 14736) for inflammatory bowel disease