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MI creates multiple complete datasets and is thereby suited for conducting a series of exploratory and secondary analyses including estimation of an optimal treatment regime (Shortreed et al. 2011).
As these sub-domain analyses were exploratory and secondary, the same threshold for multiple testing (p < 0.003) was used when interpreting the results.
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The study is an exploratory one, using both primary and secondary data.
The pragmatic sample size of 120 participants for the trial was selected with reference to the general rule of thumb recommended by Lancaster et al. [ 27], taking account of the factorial design of this exploratory trial and the primary and secondary outcome measures to be investigated.
Because of the multiple statistical testing of the numerous variables measured, all other intergroup comparisons have to be interpreted in a secondary, exploratory, and hypotheses-generating, rather than confirmatory, manner.
Digit ratios were neither related to any of the reproductive and secondary sexual traits or exploratory behaviour measured.
Two-year end points were defined as secondary or exploratory and included change in total Genant-modified Sharp score (mTSS), total erosion score and joint space narrowing score from baseline to week 104.
Improved knowledge of reproducibility for functional imaging will guide further development and incorporation as exploratory or secondary endpoints in multi-centre phase I/II clinical trials of cancer therapeutics in children, particularly those that have an antiangiogenic effect.
Secondary outcomes are exploratory and supportive of the primary outcomes.
However, these secondary objectives are exploratory and may generate new hypotheses and give direction for future studies.
In this exploratory study, our secondary endpoints were rate of rise and fall of biomarker concentrations and absolute magnitude of biomarker concentration.
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