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A list of eligible children was ordered according to age and village, and matched to the list of randomization card numbers, generated in the UK.
This list contains the numbers 1 to 500 and consists of 125 blocks of 4. The list of randomization numbers and corresponding treatment (placebo or ciprofloxacin) will be saved in an independent database with restricted access by the pharmacist.
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The Statistical Programming department at Forest Research Institute generated (using SAS, v. 9.1.3; SAS Institute Inc., Cary, NC, USA) and maintained a list of randomization codes in a secure area.
Randomization was scheduled every week after preparation of the list of patients.
Two lists of randomization (one per stratum) were used to code radiographs (using an alphanumeric code).
To assure these qualities, the randomization list of this randomized controlled trial will be computer-generated and will remain concealed until the participants' assignment to each group.
From a list of random numbers, instructions for randomization were prepared in sealed envelopes for each patient before the start of the study.
All eligible participants will be randomized to either the intervention or wait-list control group according to a list of random permutations prepared by block randomization performed by a person not involved in subject recruitment.
Patients were randomized with a 1 1 allocation ratio using a simple randomization procedure (computer generated list of random numbers prepared by an independent person not involved in the study) to either the Intervention group (butyrate, n = 40) or the Placebo group (normal saline, n = 40).
The algorithm generates an ordered list of the possible permutations of randomization within each block – at the top of the list are the permutations which minimize imbalance the best.
The randomization list included the randomization codes, patient identifier and assigned imaging modality.
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CEO of Professional Science Editing for Scientists @ prosciediting.com