Adverse events will be assessed based on inquiries to the mothers. All adverse events will be evaluated by the investigator for severity. An adverse event will be defined as any event that will not be consistent with the information provided in the consent form or that could not reasonably be expected to accompany the natural history and progression of the subject's condition throughout the study. Adverse events will be considered serious if fatal or life-threatening, require hospitalization or surgical intervention, result in persistent or significant disability/incapacity or are considered to be medically relevant by the investigator. All other adverse events will be categorized as non-serious.