Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

Inclusion Criteria:

• Participant is within the approved age range as per labeling recommendations.Participants aged 1 to 3 years who are in the FibroScan subset will not undergoFibroScan assessments until they reach 4 years of age.

• Participant is either on existing Epidiolex therapy for treatment of a seizuredisorder or is to be started on Epidiolex for treatment of an Food and DrugAdministration (FDA)-approved indication.

• Participant is willing to refrain from strenuous exercise 48 to 72 hours prior toall study visits with the exception of unscheduled visits.

• Any non-pharmacological therapies (e.g., ketogenic diet) must also be stable up to 4weeks prior to Screening Visit and expected to be stable throughout the duration ofthe study.

Exclusion Criteria:

• Participant is currently using or within 3 months of screening has used recreationalor medicinal cannabis, or synthetic cannabinoid-based medications, not includingEpidiolex if currently prescribed.

• Participant is not planning to abstain from using recreational cannabinoids ormedicinal cannabis, or synthetic cannabinoid-based medications during the study.

• Female participant is pregnant (positive pregnancy test), lactating or planningpregnancy during the course of the study and for 3 months thereafter.

• Participant has any other significant disease or disorder which, in the opinion ofthe investigator, may either put the participant, other participants, or site staffat risk because of participation in the study, may influence the result of thestudy, or may affect the participant's ability to take part in the study

• Participant has diseases or disorders which are associated with liver fibrosis witha FibroScan score of ≥ 6.5 Kilopascals (where FibroScan results are available).

• Positive serology panel (including hepatitis B surface antigen and hepatitis C virusantibody) and/or positive human immunodeficiency virus antibody/p24 antigen screensat screening.

• Following a physical examination, if the participant has any abnormalities that, inthe opinion of the investigator, would prevent the participant from safeparticipation in the study.

• Participant has significantly impaired hepatic function at Screening Visit alanineaminotransferase or aminotransferase > 3 x upper limit of normal (ULN), and totalbilirubin > 2 x ULN or international normalized ratio > 1.5.

• Participant is planning to have epilepsy surgery or other major surgery within fiveyears.

• Participant has or plans to have any medical device implanted that iscontraindicated for use with FibroScan (only applicable for FibroScan subset), withthe investigator consulting with the Sponsor as needed.

• Participation in any clinical trial involving an investigational medicinal productwithin 3 months prior to the Screening Visit or at any point during this study.