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This included examining national and international safety reporting guidance, reviewing serious adverse event reporting procedures from other pharmacological and non-pharmacological trials, a review of the literature and collaboration between the ACTION study team and Data Safety Monitoring Committee

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In a clinical trial, an adverse event is any untoward medical occurrence that is experienced by a trial participant which is not necessarily related to the intervention [12]

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Thats not an abstract regulatory complaintit directly affects safety and predictability