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Table 1 Summary of Infant Demography, Baseline Characteristics, and Disposition

From: Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety

   Gold Gold + Lutein Total
   (n = 115) (n = 115) (n = 230)
Age (days)     
  n 115 115 230
  mean ± SD 9.5 ± 3.42 10.0 ± 3.49 9.8 ± 3.46
  min - max 1 - 14 2 - 14 1 - 14
Gender     
  Female (%)/Male (%) 60(52)/55(48) 58(50)/57(50) 118(51)/112(49)
Weight Mean ± SD 3169.1 ± 306 3216.6 ± 355 3193 ± 331
Study Disposition (%) 1     
Infants Screened     240
Infants randomized2   116 116 232
Completed the Study   110 (95) 110 (95) 220 (95)
Discontinued the Study   6 (5) 6 (5) 12 (5)
Reason for study discontinuation (%)     
   Adverse Event   4 (3) 3 (3) 7 (3)
   Parent/Legal Guardian Request   2 (2) 3 (3) 5 (2)
  1. Population: Intention to Treat
  2. n = Number of randomized subjects who received study formula.
  3. 1 The denominator used to calculate percent for study demographics is the number of subjects who received study formula.
  4. 1 The denominator used to calculate percent for study disposition entries is the number of subjects randomized.
  5. 2 Two subjects were randomized (one in each formula group) but did not receive study formula.