Table 1 |
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|
Summary of Infant Demography, Baseline Characteristics, and Disposition |
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|
Gold |
Gold + Lutein |
Total |
||
|
(n = 115) |
(n = 115) |
(n = 230) |
||
|
|
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|
Age (days) |
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|
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 |
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|
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 |
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|
Infants Screened |
240 |
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|
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 (%) |
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|
Adverse Event |
4 (3) |
3 (3) |
7 (3) |
|
|
Parent/Legal Guardian Request |
2 (2) |
3 (3) |
5 (2) |
|
|
|
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|
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. |
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|
Capeding et al. Nutrition Journal 2010 9:22 doi:10.1186/1475-2891-9-22 |
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