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For each phase the main study procedures are described below.
Standard operating procedures were written for all the main study procedures including anthropometric measurements and the oral glucose tolerance test.
These pilot participants then entered an extension phase in which main study procedures and instruments were tested with this group, so as to resolve any technical glitches prior to deployment with main study participants.
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Principal investigators may have preferences about the timing of nested studies, but whether they begin at the start or after a baseline is established for the main study, clear procedures should be put in place and above all adequately resourced.
A pilot study of 75 non-smoking women had been conducted before the implementation of the main study to test study procedures and feasibility.
These stabs were intended to mimic the fact that most groups in the experiments of the main study underwent an experimental procedure in the adult stage, and therefore the results from this experiment could potentially infer information about the patterns in phenoloxidase levels that may have occurred in the main study.
In addition if the results are unfavorable or the authors find an unfeasible procedure, the main study is less likely to be considered useful.
Treatment procedure The main study was intended to determine whether the use of chlorhexidine solution prior to restoration of the cleaned cavity would result in higher restoration survival rates.
Two main study visits including CT volumetry (procedure described below), questionnaires, 24 hour and spot urine collection will take place at start (week 0) and end of treatment (week 24).
In a study that closely mirrored the experimental procedures of the main study presented here, we asked if the results could be driven by a resource trade-off.
Patients were evaluated at study sites at 6 and 12 weeks, and BP recorded in accordance with procedures for the main study.
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