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In this phase II trial, the planned sample size was 45 patients, which was calculated by Southwest Oncology Group's two-stage attained design 9 based on an expected clinical complete remission rate of 60% and a threshold of 40%, with an interim one-sided alpha of 0.02 for futility, final alpha of 0.105, and a power of 0.9.
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EGR helped design the trial, managed the trial, planned this analysis, and drafted the manuscript.
For the randomised controlled trial, the plan is to recruit at least 130 community-dwelling persons 70 years or older from the target group.
The planned trial start date is January 2015 with an end date of May 2017 and a planned publication date of January 2018.
JKD, HW, DF, and SMB conceived of the trial and planned the data analysis, wrote and revised the manuscript.
All authors will participate in the planned EAST trial.
The monitoring plan for this study is appropriate for the planned pragmatic trial.
The planned intervention trial was piloted at North Richmond Community Health (NRCH) in 2010 2011.
TZ, EP, MS designed the trial and planned the protocol.
JW conceived of the study and secured funding, coordinated the ethical approval, coordinated the trial management group, planned the protocol and conducted the analyses.
The main outcomes of the trial, planned social network analyses and secondary data exploration will be presented at future conferences and published in the peer-reviewed literature.
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