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During sequential administration, increasing the lipid dose of Doxil in each dose by the addition of empty PEGylated liposomes strongly attenuated the magnitude of the ABC phenomenon during the effectuation phase of a second and third dose of Doxil.
Peak responses for anti-CS GMTs were observed in the 0,1,2-month schedules, which was an unexpected result as, in line with licensed Hepatitis B vaccine schedules, trials with a hepatitis B vaccine have shown that increasing the interval between the second and third dose enhances humoral response [23], [24].
The analysis by dose for the combination of six antigens indicated that the increase in the rate ratio was confined to the first dose: the rate ratio for the two "Hexavalent products" was 2.2 (95% CI 1.1 to 4.4) in association with the first dose, and 1.0 (95% CI 0.5 to 2.1) for the second and third dose combined (Table 5).
No DLTs were observed in the second and third dose levels, initially.
These symptoms usually disappear shortly after vaccination and the incidence decreases with the second and third dose of vaccine.
The median age at vaccination was 1.8, 2.9 and 3.9 months for first, second and third dose, respectively.
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In the bacterial vaginosis study, intercourse between the second and third doses had a negative association with preterm birth.
Patients who were randomly selected to receive metronidazole were analyzed for bacterial vaginosis and T vaginalis at 24 to 29 weeks and for preterm birth of <37 weeks of gestation, according to intercourse between first and second doses and between the second and third doses.
In the T vaginalis trial, sexual intercourse between the first and second doses or between the second and third doses did not influence the incidence of preterm birth (13% vs 17%; relative risk, 0.8; 95% CI, 0.3-2.1; and 16% vs 17%; relative risk, 1.0; 95% CI, 0.6-1.6; respecompared compared with no intercourse.
In the bacterial vaginosis trial, although sexual intercourse between the first and second doses did not influence the incidence of preterm birth (11% vs 12%; relative risk, 0.9; 95% CI, 0.6-1.5), sexual intercourse between the second and third doses was associated with a reduction in the incidence of preterm birth (10% vs 16%; relative risk, 0.6; 95% CI, 0.4-0.9 0.4-0.9ed with no intercompared
Following the first dose, the second and third doses were given in 24-hour time intervals in both protocols.
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