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Due to limitations with this cell line [ 30, 31], prospective agents should also be trialed on primary mesenchymal stem cells, however in the case of SB431542 this data was already available [ 23].
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Several ongoing randomized controlled trials of HRT are focusing on primary or secondary prevention of coronary heart disease.
The models were based on primary data from an epidemiological trial [38] and reproducing the model predictions without access to this data may prove difficult.
There is a clear need for randomized trials on primary CVD prevention in older people (with inclusion of the frail older person with comorbidities) measuring outcomes that are meaningful to older people, to enable evidence based decision making for this group.
The Swedish randomised controlled trial on primary HPV screening was started in 1997 and compared with previous studies reporting on the longitudinal performance of HPV screening; this study contributes a considerably longer follow-up time.
The sample size for the main trial will be based on the primary outcome measures: WOMAC pain and function subscales [ 48] and will compare 6 months post-randomisation outcome for the usual care group with either of the two other intervention groups.
Usually, sequential designs for clinical trials are applied on the primary (=efficacy) outcome.
The sample size for this trial was based on the primary outcome.
The sample size for this non-comparative phase II trial was based on the primary end point, ORR.
The first report of the results of the BIG 1-98 trial was based on the primary core analysis, which was published in 2005 [ 1].
The boundaries for the sequential trial were calculated on the primary outcomes of a difference of cervical dilatation ≥1 millimetre, with the assumption of a type 1 error of 0.05 and a power of 0.95.
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