Follow up Study of Patients Having Participated in Clinical Trial 64,185-204

A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204

The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.

Outcomes will be based on the following variables:

Reported AEs and SAEs Hearing assessments Developmental assessments

Inclusion Criteria:

• Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204
• Parents or guardians have given written informed consent to participate