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The implementation of this trial was cleared by the health ministry steering committee of government of India.
The successful implementation of this trial will provide strong evidence on which to base judgments regarding the efficacy of this intervention approach.
The authors wish to thank the research clinicians and staff participating in the trial and study collaborators for their input during the design and implementation of this trial.
Further community-based trials are being planned for settings in sub-Saharan Africa, and lessons learned from the design and implementation of this trial might provide guidance to the conduct of those trials.
The implementation of this trial in a "real world" setting has allowed findings to be more generalisable to primary health care, as they have been performed in a setting in which future implementation is likely to occur [ 14].
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During the design and implementation phase of this trial, unanticipated challenges arose, requiring flexibility to address them.
Seroyal did not provide any other support and had no input over the design or implementation of the trial, nor did they review this manuscript prior to publication.
"The most significant deficiency in the implementation of the trial was the obtaining of consent," said one finding.
This article outlines some of the shortcomings of designing and carrying out clinical trials, as well as inadequacies concerning the publication, interpretation, and implementation of the trial results.
Without the formative research, several significant areas would have been undetected and may have jeopardized the implementation of the trial.
"I welcome Newport's implementation of the trial express service to cater for demand and look forward to it being successful".
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