Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
Observational follow-up of participants from earlier interventional trial 64,185-202
 (NCT00850993).

 No interventions were administered during this follow-up study.
Inclusion Criteria:

 Participants who received treatment in clinical trial 64,185-202 and for whom informed
 consent was given for long term safety followup

 Exclusion Criteria:

 Participants were excluded by the investigator for medical reasons or by parents/guardians
 withdrawing consent