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Subjects received one dose of vaccine on Day 0 and one dose on Day 21 (ATP cohort for immunogenicity and persistence).
A number of other extended regimens were considered, including giving a 1 g dose on day one in order to comply with treatment guidelines for C. trachomatis, and then supplementing with 250 mg on days two to five.
Sitagliptin 200 mg given once daily for five days to 12 patients (nine men and three women) did not alter the pharmacokinetics of simvastatin given as one 20 mg dose on day 5 of sitagliptin therapy.
Each subject received XEN-D0501 and placebo (in random order) twice daily for 13 days, with a final single dose on day 14.
Peripheral blood for biomarker analysis was collected before and 6 h after the first dose on day 1 and at every visit thereafter (i.e., every 14 days for the first 12 weeks).
Subject eligibility was determined at the screening visit (up to 35 days before treatment initiation) and confirmed at baseline before the first dose on day 1.
Three additional PK samples were collected from each patient: between 3 7 days after the first dose, between 10 15 days after the third dose and prior to the fourth induction dose on day 64.
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Ewes from the third group (HD + RE; n = 95) remained isolated from males until Day 0, and received a dose of PGF2α on Day-13, and a half-dose on Day 0. On Day 0, the three groups were joined.
Allergen challenge was performed 1 h post-dose on day 21.
A subject in the MAD study, who withdrew consent post-dose on Day 1, was replaced.
All animals were killed 3 h post-dose on day 7 and the tumors harvested.
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CEO of Professional Science Editing for Scientists @ prosciediting.com