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Baseline characteristics at randomisation were comparable both between the respondents and the non-respondents, and between originally allocated groups.
Patients were blinded to their allocated group.
The SRA is blind to the participants' allocated group.
The participants will also know the allocated group.
The follow up visits differ according to the allocated group.
This analysis was done blinded to the allocated group.
We did this analysis blinded to the allocated group.
Randomly allocated groups were well matched on the measured variables.
Participants will be allocated to the group by the Study Coordinator, and will be aware of the allocated group.
Groups were analysed with intention-to-treat according to the allocated group.
Each infant remained in the initially allocated group throughout the study.
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