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Costs will be assigned using standard costing sources [ 24].
To ensure allocation concealment, the block size will not be disclosed and allocation will be assigned using sequentially numbered, opaque, sealed envelopes.
Quantities of resource use will be measured and unit costs (prices) will be assigned, using current pay rates, commercial rates (prices) and individuals' reported out-of-pocket costs.
Assignment schedules will be generated for each clinical site, and each patient will be assigned using a web-based system (Studymaker.com) managed by the MCC.
Similar(55)
Alleles were assigned using GeneMapper Software v37 (Applied Biosystems).
Haplotypes were assigned using PHASE (version 2.1).
Participants will be assigned random numbers using a random number generator program (Microsoft Office Excel 2007).
Eligible participants will be assigned to each group using blocked randomization, stratified by the participating centers, with a 1 1 allocation ratio using a confidential block size.
Even if the company passes its next Food and Drug Administration inspection and is allowed to resume production, the first several million doses will be assigned for military use.
Unit costs will be assigned to resource use observed for each individual, in order to estimate total costs.
An overview of the study design is given in figure 4. A computerised randomisation schedule will be prepared by an independent researcher, and using concealed allocation each patient will be assigned to one of three treatments using numeric block randomisation.
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