Doses were given at enrolment and repeated 4 weeks from baseline.
We therefore tested whether missing doses of DTP at enrolment was associated with increased female mortality in other trials of MV, which had documented DTP vaccination status at the time of enrolment, and where DTP and MV were not administered simultaneously.
25 However, girls vaccinated with measles vaccine who were missing doses of DTP vaccine at enrolment and were likely to receive additional doses during follow-up had twofold higher mortality than did girls who had received three doses of DTP vaccine before enrolment.
The excess female mortality increased significantly with the number of doses of DTP missing at enrolment and therefore likely to be given during follow-up.
Sensitivity, subgroup, and stratified analyses showed no effect of potential sources of systematic errors or subgroup specific effects (inclusion of the unvaccinated cohort, number of doses, age at conception, age at enrolment, gestational age of miscarriage).
If two or more patients presented with DLT at a dose level, enrolment of patients to that dose level was discontinued and the immediately preceding dose level was considered the MTD.
The latter trials varied widely in gestational age at enrolment 14-366 weeks gestation), dose and type of imidazole (1%-21%-2%otrimazole, miconazole & econazole), duration of imidazole therapy (1-14 dand) and the duration between treatment and follow-up [ 11].
Significant differences between groups at enrolment were observed for the morphine dose.
We also analysed VE in a MITT population that included subjects who were HPV 6, 11, 16, or 18 naïve at enrolment and that received at least one dose of vaccine or placebo, regardless of general protocol violations (Table 3).
