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Among the primed subjects who were in study stage 2 (two subjects in F17 and two subjects in F19), the tetravalent rate was 100% on the day of dose 3 and 1 month later.
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A predose urine sample was collected prior to the administration of the oral dose, and 10 subsequent urine samples were collected, one for each of the 10 days after the day of dosing.
In the phase 1a study, whole blood specimens were collected at screening visit day 1, pre-dose on the day of dosing, post-dose on days 14 and 28 for all dose groups, day 42 for the 3.0 and 6.0 mg/kg dose groups, and at the extension/follow-up for all dose groups.
Body weight was measured immediately before treatment on the day of dosing (day 1) and on days 2, 4, 8, and 15.
The body weight was measured on the day of dosing (Day 1) immediately before treatment, and on Days 2, 4, 8, and 15.
11 subjects were enrolled with 3 participants being withdrawn after the first day of dosing.
Consistent with a reduction of cortical mGlu5 receptor density and phosphorylation, CDPPB (30 mg/kg) significantly affected sleep architecture as determined by cortical EEG at day one however by the seventh day of dosing all sleep changes were absent.
The drug solutions were prepared each day of dosing.
Steady state was achieved on the third day of dosing.
15 A dose-dependent reduction in plasma glucose occurs within the first day of dosing.
Dilutions of the stock solutions were made each day of dosing.
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