Clinical Research Directory

Inclusion Criteria: Inclusion Criteria: * Male or female participants must be 6 to 17 years of age (inclusive) * Participants must have completed study intervention in their lead-in study Exclusion Criteria: * Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments. * Participant has known allergies or hypersensitivity to opioids * Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study. * Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy). * Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction * Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction * Participant has a history of chronic or severe constipation, or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction * Participant has renal impairment or an unstable hepatic, metabolic, or hematologic condition. * Participant is a current regular alcohol drinker and/or binge drinker\*, and/or has a history of alcoholism, alcohol abuse (eg, binge-drinking\*), or alcohol addiction, and/or intends to consume alcohol during the study