A 5-Year, Extension, Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202

INTERVENTION: Product Name: Stannsoporfin Pharmaceutical Form: Injection* INN or Proposed INN: STANNSOPORFIN CAS Number: 106344201 Other descriptive name: Stanate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intramuscular use CONDITION: Neonatal hyperbilirubinemia Hiperbilirrubinemia Neonatal ; MedDRA version: 12.1 Level: LLT Classification code 10020580 Term: Hyperbilirubinaemia neonatal PRIMARY OUTCOME: Main Objective: To evaluate any potential long‐term effects of stannsoporfin (Stanate) on the health, growth, and development of subjects who received a single dose of stannsoporfin compared with subjects in the control (placebo) group in clinical trial 64,185‐202. Primary end point(s): Las evaluaciones de la seguridad se basarán en las siguientes variables:; · Acontecimientos adversos notificados (EA); · Historial de enfermedad, incluida hospitalización; · Mediciones de las constantes vitales; · Exámenes físicos; · Exámenes auditivos; · Exámenes oculares; · Exámenes neurológicos; · Análisis clínicos de laboratorio Secondary Objective: None INCLUSION CRITERIA: ‐ Sujetos que hayan recibido el PEI en el ensayo clínico 64.185‐202 ‐ Consentimiento informado escrito Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range