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An equal number of participants will be randomised to each group (1 1 1) using a randomised block design, with a block size of six, to ensure the study groups are balanced [ 39, 40].
In the first stage (the preliminary study), 150 patients will be randomised to each arm.
The planned sample size of 102 evaluable patients allowed for 34 patients to be randomised to each treatment arm.
To take this into account, we aimed to recruit 240 mothers to be randomised to each study group.
Assuming a 35% patient dropout rate of patients, then 400 patients will need to be randomised to each group.
Given the chosen precision for HbA1c and an expected dropout of 15 20%, 59 participants were to be randomised to each treatment group.
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Twenty-two patients were randomised to each treatment arm.
Of the 40 evaluable patients, 20 were randomised to each arm.
A total of 44 patients were randomised to each treatment arm.
One hundred and twenty (87.5%) agreed and 60 were randomised to each arm.
Two randomised controlled trials compared sequential therapy with hybrid therapy: 300 patients were randomised to each treatment.
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