• study
  • Signed informed consent by the patient and/or parents/legal guardian was obtained as soon as it is confirmed that the patient met inclusion/exclusion criteria and the parents/guardian would agree for the child to participate in the study. (clinicaltrials.gov)
  • Compare the frequency and severity of neurological disability of study patients with untreated historical controls. (clinicaltrials.gov)
  • While this study will be registered with clinicaltrials.gov, no specific patient recruitment materials will be utilized. (clinicaltrials.gov)