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Having three rounds avoids excessive participant fatigue and maximises the potential to reach consensus amongst participants [41].
Parents were not required to consult the parent-held record due to concerns that excessive participant burden might adversely impact the response rate.
Experience in the use of adipose tissue sampling in epidemiologic studies in various countries has shown that it is simple to conduct, requires little training, carries little risk, and does not result in excessive participant refusal.
Secondary outcomes are not part of our sample size calculations (which is normal practice) but we believe they will add value without excessive participant burden and will be available for future meta-analysis/review purposes and hypothesis generating in this area.
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Of these, six were excluded before preprocessing due to failure to complete the task (two participants), excessive response times (two participants), incidental findings (one participant), and corrupted fMRI data due to excessive movement (one participant).
Three participants were excluded from analyses due to technical problems (2 participants) or excessive head movement (1 participant).
The analysis included data from 16 of these participants (11 women, 5 men; mean age ± SD: 22.9 ± 1.9); the data from the other 3 participants were excluded due to a program error (2 participants) or to excessive head motion (1 participant).
"The issues are in those small number of cases where collaboration occurs in a way that gives participants excessive marketplace power," said Deborah Feinstein, director of the bureau of competition for the FTC.
It is possible that our explicit feedback was excessive and led participants' reliance on feedback even though we progressively lowered feedback frequency.
The intensive assessment was carefully paced to allow rest periods, avoid rushing and prevent excessive burden to participants.
A six month follow-up period is the longest we consider to be clinically feasible without excessive loss of participants due to clinical decline and death.
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