Study population
respiratory tract infections, colic
RESPIRATORY TRACT INFECTIONS, DISEASE
The present study was based on a randomized, double-blind, placebo-controlled clinical trial (ClinicalTFollow-up visits were scheduled at the ages of 1, 2, 4, 6, and 12 months by the same study nurse. During all study visits, the infants were clinically examined, and a detailed report was obtained from the parents of the infant’s behavioral patterns, to record any symptoms or signs of disease. The diagnostic protocols for respiratory tract infections and colic have been described in detail previously.Healthy full-term reference subjects (This study complied with the Declaration of Helsinki, as revised in 2000. Written informed consent was obtained from the parents of the infants, and the study protocols were approved (11/2007 § 427) by the Ethics Committee of the Hospital District of South-West Finland.