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Probiotic trials need to standardize their methods for evaluating BV and given the high recurrence rates reported in trials that extend follow up to 6 12 months [ 40, 42], studies with more prolonged of observation post-treatment are important.
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Data from extended follow up are included [18].
The study and extended follow up has been described in detail elsewhere [18], [21].
This would be particularly relevant to the asymptomatic group as subsequent follow up data revealed that nearly 75% (n = 196) of 262 asymptomatic women experienced symptoms suggestive of HSV-2 reactivation during extended follow up.
Though the low levels of circulating genetically modified cells observed in our trial prevent a definitive interpretation, the absence of clonal outgrowth during extended follow up suggests that our integrations better reflect normal in vivo hematopoiesis.
Children were followed for 76 weeks post-randomization and then re-enrolled in extended follow up.
Extended follow up is important for accurate assessment of blood pressure among African children.
However, only a minority of our children had sustained HBP on extended follow up.
BNP was also a stronger predictor of survival over an extended follow up period of 5 years.
However, extended follow up shows that this high level of improved compliance was not sustained as shown by decline in Phases III and IV.
While studies in adults suggest a high prevalence of hypertension, this study among children, with extended follow up, suggested a prevalence of HBP in keeping with international norms.
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