The most frequent comorbidity at enrolment was hypertension, reported in 38.5% of patients.
The cohort had a mean age of 55 years and a moderately altered physical performance (mean KPS: 81; most frequent symptoms on enrolment: cephalalgia, alterations in higher cerebral functions, long tract signs and epilepsy in six out of nine, four out of nine, eight out of nine and three out of nine patients, respectively).
In Table 3, we see that the use of a longitudinal data source has been most frequent among studies where school enrolment is the main outcome variable (10 publications).
Otalgia and antibiotic use before enrolment were significantly more frequent before than after PCV7 implementation, with no significant change in type of antibiotic prescribed 3 months before enrolment.
Inclusion criteria also included age between 18 and 80 years at time of enrolment, physical condition allowing frequent walking after the procedure, and availability to complete study requirements.
They were also more likely to have history of CVD and cancers (all p < 0.05), poorer renal function (higher ACR, lower eGFR) and more frequent severe hypoglycaemia events (both at enrolment and during follow-up) (p < 0.0001) (Table 1).
The hypothesis was that measured blood loss of 500 ml or more in the hour after enrolment would be significantly less frequent in the misoprostol than in the placebo group.
Enrollees with longer years of service, poorer health condition, frequent hospital visits and longer duration of enrolment in the health insurance scheme were also expected to be more satisfied.
In the placebo group, the primary outcome (measured blood loss within 1 hour after enrolment of 500 ml or more) was less frequent (9.2%) than the 25% prediction on which the sample size calculation was based.
In patients with a lesser response, local relapse was frequent (60% of patients) and occurred up to 4 years after enrolment.
