The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in n-6:n-3 ratio between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in Effortful Control Composite scores between groups (DHA+AA vs. Placebo).

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in Activity Level Composite scores between groups (DHA+AA vs. Placebo).

A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.

Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in Cognitive Composite scores between groups (DHA+AA vs. Placebo).

A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.

Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in Language Composite scores between groups (DHA+AA vs. Placebo).

A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.

Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in Motor Composite scores between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the change in daytime sleep duration between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the change in total sleep duration between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in weight-for-age z scores between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in length-for-age z scores between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in head circumference-for-age z scores between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in mid upper arm circumference-for-age z scores between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in triceps skinfold-for-age z scores between groups (DHA+AA vs. Placebo).

Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.

Threshold for statistical significance (<0.05)

The reported p-value is for the comparison of the change in subscapular skinfold-for-age z scores between groups (DHA+AA vs. Placebo).

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the change in Daytime Sleep Duration between groups (DHA+AA vs. Placebo).

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the change in Total Sleep Duration between groups (DHA+AA vs. Placebo).

Continuous scores at the end of the trial were compared using a linear mixed model.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).

Linear mixed models compared continuous scores at follow-up between treatment groups.

Threshold for statistical significance (<0.05).

The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).