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The development of the trial in terms of design factors such as sample size estimates and the selection and randomization of communities to intervention or comparison is described.
Development of the trial protocol, design of the Radio Frequency (RF) coils and Quality Control procedures necessary to ensure that the datasets acquired at each centre were comparable, are described.
SA contributed to the development of the trial protocol.
Development of the trial was informed by earlier feasibility work.
All of the authors contributed to the design and development of the trial protocol.
This enables the researcher to have more freedom for the development of the trial.
RJD, JB and HWFE contributed to the development of the trial protocol.
All authors contributed to the design and development of the trial protocol.
JMD, CAC, RRH, JSR all contributed to the development of the trial protocol.
All authors contributed to the study design and development of the trial protocol.
SEM, AJCF, MKD, LMJ, MLJ, & AMP all contributed to the development of the trial protocol.
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