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All patients provided written informed consent for the study procedures.
Fig. 1 The CONSORT diagram for the study procedures.
The Kenyatta National Hospital Ethics and Review Committee reviewed and provided approval for the study procedures.
Please see Fig. 1 for the study procedures and participant flow chart.
In order to ensure a highly standardized data collection, all study personnel is specifically trained for the study procedures.
Written informed consent for the study procedures was obtained from each patient before initiating any study-specific procedure.
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See Figure 1 for overview of the study procedure.
Details of the study procedure for the initial study (1996 1998) have been described elsewhere (Eskenazi et al. 2000).
Details of the study procedure for the first follow-up study (study I) are presented elsewhere (Eskenazi et al. 2000).
Those for whom the study procedures were not feasible due to severe dementia, unstable medical condition, or non-English fluency, were excluded.
Prior to the actual implementation of the educational intervention, the study investigators collected comments from the community health care providers, representatives of workers and administrators of the factory for refining the study procedures and ascertaining a successful implementation.
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