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In the next year or so, Coyle expects the first clinical trials from CTIs to start, with three to five candidate proteins identified for trials each year, starting in 2013.
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Similar discrepancies have been identified for drug trials by comparing trial data reported in FDA New Drug Applications with the data in corresponding publications.
The three central ethical questions identified for pragmatic trials are: (i) what level of oversight should pragmatic trials require; (ii) do randomized patients face additional risks; and (iii) is a waiver of informed consent ethically defensible?
Changes in the secondary outcomes were identified for six trials and primarily included introduction of additional outcomes (eg, compliance) or omission of outcomes (eg, quality of life).
The outcome measure, peak power (W/kg, normalized to body mass (BM)), was identified for each trial and averaged across three trials for analysis.
Following routine quality control surveillance by the study sponsor, data quality issues were identified for one trial site.
Participants who were identified for the trial while still receiving active treatment for their index episode were randomized once treatment of the index episode was complete.
Practices identified for each trial are given in Table 2, where a cross indicates that data on a given practice were available.
KAMs during stance will be calculated using an inverse dynamics approach, and the peak KAM (first peak) will be identified for each trial [ 4, 19].
Sponsorship for the phase I trials was identified for 66 of the trials with RT and 58 of the trials without RT.
By chance, the alleged paymaster and the alleged propaganda chief were the first ones identified for war crimes trials by the Pentagon back in 2004.
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