Endpoint for Study Period III (24 weeks) was defined as the last nonmissing observation obtained from Visit 4 through Visit 13.
Values measured at visit 2 were lower than values obtained at visit 1 both in men and in women.
However, post-hoc Steel tests demonstrated that Nugent scores obtained at visit I did not differ significantly from those obtained at visits III V in either group.
Table II lists measurements to be obtained by visit.
Patients were seen every 6 12 weeks and had blood samples obtained each visit.
Baseline was defined as scores obtained at Visit 2, before randomization.
We obtained ER visit records for wheezing and gastroenteric disorder from six Italian cities.
All baseline assessments were obtained at visit 1 (within 3 weeks before start of treatment).
Additional laboratory samples will be obtained at Visit 9 for chemistry profile and lipid profile, FBC, perform dipstick urinalysis.
At each point verbal consent was obtained to visit the mother at home, to administer questionnaires and conduct observations.
