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However, two subjects were excluded because of serious irregularities: one received the same treatment in both periods and the other provided dates of dosing in the second treatment period that were earlier than those in the first treatment period.
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As mothers of migrant children always forgot the due dates of doses, the social mobilization teams could remind mothers about the date of a due dose and inform the vaccination session day through visiting their family.
The types of registry errors identified in the limited number of previous studies include: errors in transcription of number or dates of doses administered, and errors in transcribing vaccine formulation, manufacturer, or lot number [ 25, 26].
As patients had to use the same dose for at least 3 days to reach a steady state, the start of therapy or the last date of dose change was recorded.
We estimated the attributable risk of fever by subtracting the incidence proportion in the geographically separate unvaccinated population from 18 to 21 November 2011 (the median date of doses administered in the campaign districts), from the incidence proportion among vaccinees in the 3 days following vaccination.
The dates, locations and dosing strategies of these 7 studies are summarized in Table 1.
During the study period, the owners had to keep a patient diary for recording of occurrence and type of seizures, adverse events, dates and times of dosing, and potential changes in concomitant medication.
Prescription of cART (drug, dates of use, and dose) is documented by the medical provider and support staff in the clinical records.
In both cases, the dose, dosage interval, and start date and times of dosing were described.
PFS was calculated from the date of first dose of study drug administered until the date of first documentation of recurrence/progression or death due to any cause; patients were otherwise censored at the last evaluation.
∎ Date of second dose was earlier than date of first dose.
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