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Known risk factors include, among others: the expected benefits and opportunities related to the collaboration and the companion diagnostics may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development

These medications require careful dose escalation and ongoing medical monitoring to maximize benefits and minimize side effects

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This concern is particularly relevant for patients with stricturing CD, in whom up to 50% develop fibrostenotic complications within 10 years of diagnosis (74)