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The inclusion criteria were
essentially women who had the clinical condition of PID. As I mentioned previously, PID is
actually fairly difficult to diagnose, and we know that in any group of women who have
clinical PID, as many as half of them may not in fact have PID. However, this was an
effectiveness trial, not an efficacy trial; the whole point of it was to see in the real
clinical world what is better in terms of inpatient versus outpatient treatment for PID,
in terms of preventing the long-term complications of infertility, chronic pelvic pain,
etc. So we took all those comers knowing that we were going to have a mixture of women who
did and did not have the disease, but these are the kind of women that present to their
doctor. We did enhance the definition a little by saying they had to either have
Leukorrhea or Mucopurulent Cervicitis - white blood cells in their vaginal vault or in
their cervix, indicating that they had an infection – and/or they had to have untreated
Gonorrhea or Chlamydia. |