Exact(4)
Cervical swabs for HPV DNA were collected by clinicians under direct visualization of the cervix at the enrollment, 12-month and exit visits, as previously described [15].
Entry and exit visits will be performed within one week of entry and exit cMR tests.
A pediatrician performed the medical assessments and discussed the participant's laboratory results at the initial and exit visits, and provided medical counseling when needed.
Because of the study's staggered follow-up period, exit visits ranged in quarterly intervals from Month 12 to Month 24 (median Month 21).Thus for the exit visit data, 12% of responses were at Month 12, 16% each at Months 15 and 18, 14% at Month 21, and 42% at Month 24 (Fig. 1).
Similar(53)
Thus, a total of 54 women were enrolled in our trial, and among those, 5 women who were in active follow-up at the time the decision to close the trial was made were prematurely discontinued from study product and followed through their exit visit.
Visit 3 was the exit visit, occurring on days 14 15.
An exit visit will include Hb measurement (Hemocue™) and appropriate referral as necessary for follow-up care.
The first patient was dosed on 15 May 2006 and the last study exit visit occurred on 6 February 2008.
The final and exit visit was at week 24 and was a repeat of the first visit in addition to a compliance assessment.
Similarly, the exit visit at the end of the program incorporated final assessments and a physical exam, as well as program results, future goals, and participant feedback.
In addition, QoL questionnaires (KCCQ and EQ-5D) are collected at the 6-month routine follow-up visit and at the 18-month routine follow-up/study exit visit.
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