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Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: ARTIs

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: ARTIsPatients were assessed monthly and every time they presented respiratory symptoms, and all the ARTIs were followed up to the complete disappearance of all the symptoms. All the physical examinations and drug prescriptions were made by one of the authors (M.D.G.T.). Antibiotics were prescribed when purulent secretions were present, or in the case of otitis or lower ARTI. The medication codes were enclosed in opaque sealed envelopes and kept available for the researcher in the study center to be opened in case of a serious adverse event. The trial began in July 1997 and was completed by April 1999. Patients were recruited from July 1997 to April 1998.
The characteristics of ARTIs were registered on the case report form as they occurred: type (upper, lower, or otitis) and number of infections (main end point), and when a child had school absenteeism secondary to an ARTI (as days out of school due to ARTIs), number of antibiotic or other drug courses (any drug course including antibiotics), duration of the treatment (days taking any medication), and time of convalescence (days elapsed to clinical cure assessed) (secondary end points). my canadian pharmacy

The end point differences between the groups were analyzed by analysis of variance (ANOVA) for repeated measures, Student’s t test, and Mann-Whitney U test using statistical software (SPSS; Chicago, IL). Additionally, the relative risks for more than six, more than seven, and more than eight ARTIs and more than one otitis were calculated, as well as the comparison of rate of patients having less than six ARTIs throughout the 12-month period by Kaplan-Meier statistics.
Two infections were counted as such only when the patient was without symptoms for at least 72 h between the end and the beginning of the episodes. A treatment course was considered as such, when at least one drug dosage for 1 day of treatment was completed.
Clinical cure was defined as the complete resolution of all the symptoms assessed. The visual analog scale for ARTI severity was a line of 114 mm with a mark on the left end with the legend “very mild” (minimal complaint; there were no limitations for normal activities), one in the middle with the legend “moderate” (complaints did not allow to perform some normal activities), and one on the right end with the legend “very severe” (major complaints did not permit any normal activity); the scale was marked only by one of the authors.
Adverse events were registered in clinical files and in the adverse report form as they occurred and were reported monthly in the case report form. The trial medications and case report forms were provided by Quimica Knoll de Mexico SA de CV BASF Pharma.