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Fig 1.

Participant flowchart.

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Table 1.

Baseline characteristics by randomisation group and response to primary outcome follow-up questionnaire at 12 months.

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Table 1 Expand

Table 2.

Primary and secondary outcomes; ASQ score at 12 months.

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Table 2 Expand

Table 3.

Subgroup analysis; Total ASQ-score of premature children (gestational age < 37 weeks) at follow-up.

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Table 3 Expand

Table 4.

Per protocol analyses of primary and secondary outcomes and in a sub-group of premature children.

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Table 4 Expand

Fig 2.

Box-plots of ASQ sub-domain and total scores at 6, 12, 22 months for premature children.

ASQ: Ages and stages questionnaire. Coms: Communication score. Fms: Fine motor score. Gms: Gross motor score. Pss: Problem solving score. Psds: Personal and social development score. BCG: Bacillus Calmette-Guèrin vaccine.

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Fig 2 Expand

Table 5.

Sensitivity analyses of ASQ score at 12 months and in the premature subgroup at 6, 12 and 22 months.

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Table 5 Expand