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None of earlier trials reported on menstrual disorders (prolonged bleeding, spotting or menstrual pain), dysmenorrhoea, other gynaecological symptoms or on secondary fertility problems after a CS.
Whereas earlier trials reported moderate protective effects on coronary heart disease and sudden cardiac death outcomes, 10 11 recent large scale primary and secondary prevention trials failed to show the efficacy of supplementation with long chain fatty acids in reducing cardiovascular diseases.
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Early trials reported clinical activity in HER-2 positive breast cancer, even in patients with prior exposure to trastuzumab suggesting the lack of cross-resistance [ 2].
Therefore, we can support the results of other trials reporting good early operative results [ 19].
Nonetheless, EBV-specific T cells can track to extramedullary sites of EBV-lymphoproliferative disease (Heslop et al, 2010) and early trial reports suggest successful responses linked to the presence of CD19 CAR-modified T cells in cerebrospinal fluid in patients with CNS leukaemic relapse (Lee et al, 2013).
The earlier Public Health Service trials reported in North America showed that reversions of the TST reactions were as frequent in the placebo groups as in the isoniazid groups, in keeping with our results [ 25].
Furthermore, early clinical trials reported promising activity when oxaliplatin was added to 5-FU-based CRT in patients with stages II III rectal cancer [ 11, 12, 19, 33].
134 While an increasing number of trials published in high impact medical journals report stopping early, only 0.1% of trials reported stopping early for benefit, which contrasts with estimates arising from simulation studies 205 and surveys of data safety and monitoring committees.
Current evidence to support this assertion is predominantly pre-clinical, with only a small number of non-randomised early-phase clinical trials reported (of combinations with anthracyclines, ATRA or DNA-hypomethylating agents).
Of the earlier trials, three randomised controlled trials reported that there were no "unanticipated" events related to treatment.
An overview of early breast cancer radiation therapy trials reported an association with vascular mortality in breast cancer survivors (Early Breast Cancer Trialists Collaborative Groupp, 2000).
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