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Table 3 Baseline characteristics and clinical genetics

From: A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

  6 months surgery 12 months surgery Overall
Number of patients XX XX XX
Baseline characteristics
 Gender
N XX XX XX
 Male; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
 Female; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Not known; n XX XX XX
 Gestational age (weeks)
N XX XX XX
Mean (SD) XX.X (XX.X) XX.X (XX.X) XX.X (XX.X)
Median (IQR) XX.X (XX.X) XX.X (XX.X) XX.X (XX.X)
(Min, max) (XX.X, XX.X) (XX.X, XX.X) (XX.X, XX.X)
Not known; n XX XX XX
 Size of cleft
N XX XX XX
Soft palate only; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Soft and hard palate; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Not known; n XX XX XX
Clinical genetics
 Ethnicity
White; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Black; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Asian; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Chinese; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Mixed; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Other; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Not stated; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Not known; n XX XX XX
 Weight at examination (grammes)
N XX XX XX
Mean (SD) XX.X (XX.X) XX.X (XX.X) XX.X (XX.X)
Median (IQR) XX.X (XX.X) XX.X (XX.X) XX.X (XX.X)
(Min, max) (XX.X, XX.X) (XX.X, XX.X) (XX.X, XX.X)
Not known; n XX XX XX
 Length at examination (cm)
N XX XX XX
Mean (SD) XX.X (XX.X) XX.X (XX.X) XX.X (XX.X)
Median (IQR) XX.X (XX.X) XX.X (XX.X) XX.X (XX.X)
(Min, max) (XX.X, XX.X) (XX.X, XX.X) (XX.X, XX.X)
Not known; n XX XX XX
 Occipitofrontal circumference (cm)
N XX XX XX
Mean (SD) XX.X (XX.X) XX.X (XX.X) XX.X (XX.X)
Median (IQR) XX.X (XX.X) XX.X (XX.X) XX.X (XX.X)
(Min, max) (XX.X, XX.X) (XX.X, XX.X) (XX.X, XX.X)
Not known; n XX XX XX
 Interpretation of DENVER-II
Normal; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Suspect; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Un-testable; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Not known; n XX XX XX
 Diagnosis
Known syndrome; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Unknown syndrome; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Severe developmental delay; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Uncertain; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Non-syndromic; n (%) XX (XX.X) XX (XX.X) XX (XX.X)
Not known; n XX XX XX
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