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Moreover, because the study randomisation was not stratified for gender, only 26 men received the intervention.
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Thursdays were chosen because this is when study randomisation normally occurred, so the first text went out exactly two weeks after entry into the trial.
Four (0.65 %) patients, out of 611 randomised, discontinued the study after randomisation, thus resulting in a total of 607 patients completing the study.
19 No additional participants joined the study after randomisation.
The British Society for Paediatric Endocrinology and Diabetes Clinical Trials Unit (Cambridge, UK) used minimisation by weighted randomisation for the study's two randomisations.
Staff at study headquarters at University Hospital of North Norway (UNN), which is not connected with the study, prepared the randomisation database and acts as a central randomisation service.
The study protocol and randomisation arms are detailed in Figs. 1 and 2 and Table 1.
An independent person, separate from the staff conducting the study, will handle the randomisation using an online randomisation tool.
A biostatistician who is independent of the study will generate the randomisation schedule using block randomisation with variable block sizes.
The study statistician generated the randomisation sequence in Microsoft Excel.
After randomisation the study number will be assigned.
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