The study design planned for 720 subjects to be randomly allocated into one of three treatment groups using a block 1 1 1 randomization list generated at GSK from a standard Statistical Analysis System (SAS) program (SAS Institute Inc., Cary, NC).
In total, 120 subjects were enrolled in the trial and randomized into three treatment groups (F17, F19, and placebo) using a block 1 1 1 randomization list from a standard Statistical Analysis System (SAS) program (SAS Institute Inc., Cary, NC).
Patients were allocated to treatment by a randomisation list generated by Abbott using a block size of 10.
The data center generated randomization lists for infants with and without birth asphyxia, using a block randomization procedure (randomization occurred within blocks of 4 or 8).
The BrowseTMA Make WSH batch file [see BrowseTMAMakeBatch.bat in Additional file 1] invokes the BrowseTMA Batch XSLT stylesheet [see BrowseTMABatch.xsl in Additional file 1] which uses a TMA block list XML file [see fileList.xml in Additional file 1] to produce a single batch file [see BrowseTMA.bat in Additional file 1].
A block list file is used in two ways.
The indexing of a block list and connections facilitates the search for neighboring blocks and the assignment of properties evaluated at the block interfaces, such as transmissibility, velocity, and mass flux using the list of connections.
Random sequences of block sizes of two, three, four or five were used, stratified by study centre using a separate block randomisation list for each of the two centres, and by random permutations of group allocation within each block.
Randomization of the pre-defined number of 28 patients was concealed, using a randomization list with a block size of four, which was generated electronically before start of the trial.
Per school, the first author randomly allocated each included child to one of the four sealant groups, using a list obtained after block randomisation (12 children per block for three operators) and prepared by a statistician who did not do the analyses.
