Serious adverse events
death
ADVERSE EVENTS, EVENTS
All study personnel will consider adverse events serious if they include any of the following:DeathLife-threatening adverse eventInpatient hospitalization or prolongation of existing hospitalizationPersistent or significant incapacity or substantial disruption of the ability to conduct normal life functionsImportant medical events that may not result in death, be life-threatening, or require hospitalization, but based on medical judgment may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above in this definition.Participants with serious adverse events will exit the intervention without unblinding the treatment intervention assignment, unless the clinical team considers unblinding essential to the provision of clinical care. The clinical team will assume the care of a participant who exits the intervention, and we will provide the current dose of opioid to the clinical team.