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Table 6 Number of Serious Adverse Events (SAEs)* reported during the study, Intention-to-Treat

From: Normal growth of infants receiving an infant formula containing Lactobacillus reuteri, galacto-oligosaccharides, and fructo-oligosaccharide: a randomized controlled trial

SAE preferred term** L. reuteri (control) (N = 68) L. reuteri+ GOS/FOS (experimental) (N = 72)
Total number of SAEs 7 14
Infection Viral 1 0
Influenza-Like Symptoms 1 0
Pneumonia (CXR/bacterial) 2 3
Vomiting 1 0
Varicella Zoster infection 1 0
Choking 1 0
Meningitis (aseptic) 0 1
Fever (>38.0 degrees Celsius) 0 4
Urinary Tract Infection (Bacterial) 0 1
Upper Respiratory Tract Infection 0 1
Rash Erythematous 0 1
Bronchitis 0 1
Apnoea Neonatal 0 1
Pharyngitis 0 1
  1. *Some infants had >1 SAE; **Coded according to World Health Organization Adverse Reactions Terminology.