Exact(60)
Two adult and three pediatric patients (aged < 18 years) were enrolled into the extension study.
Nineteen of 57 patients completed the extension study.
There were no deaths in the extension study.
No primary endpoint was defined for the extension study.
No unexpected AEs were reported in the extension study.
EC was the medical monitor for the extension study.
No serious AEs were reported during the extension study.
He participated in the extension study for 24 months.
Two patients became pregnant during the extension study.
All sample collections used for the extension study were derived from case−control studies.
Results of the extension study were combined using a Mantel-Haenszel approach (40).
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