Table 1

Summary of Infant Demography, Baseline Characteristics, and Disposition

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)


Population: Intention to Treat

n = Number of randomized subjects who received study formula.

1 The denominator used to calculate percent for study demographics is the number of subjects who received study formula.

1 The denominator used to calculate percent for study disposition entries is the number of subjects randomized.

2 Two subjects were randomized (one in each formula group) but did not receive study formula.

Capeding et al. Nutrition Journal 2010 9:22   doi:10.1186/1475-2891-9-22

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