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This benefit can only be demonstrated in randomised prospective trials, which are ongoing in the metastatic setting.
Causal relationships have to be demonstrated in randomised clinical trials but complementary informative data collection from the real-life setting is needed for health economic decision making.
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14 In addition, significant reductions in sex hormone levels have been demonstrated in randomised controlled trials of melatonin supplementation.
The survival advantage associated with dexamethasone over prednisolone in the treatment of ALL has been demonstrated in randomised controlled trials, although concerns remain regarding the relative toxicity.
The efficacy of osteoporosis medications in reducing the risk of fragility fractures in postmenopausal women with osteoporosis has been demonstrated in randomised controlled trials (RCTs), but there is only limited data that they are capable of improving patient quality of life [ 16- 20] or reduce mortality [ 21].
In RA, the beneficial effect of fasting followed by vegetarian diet on the clinical course of the disease has been demonstrated in randomised trials [ 12] and furthermore been linked to alterations of the fecal flora, as assessed by gas-liquid chromatography of bacterial cellular fatty acids [ 13].
This automated Cognitive Behaviour Training CB Trainingg) web-based program has been demonstrated in randomised controlled trials to reduce depressive symptoms in members of the community at risk of depressive disorder [ 20] and to prevent new cases of depression and anxiety in young people [ 19].
25 The efficacy and safety of TCZ in rheumatoid arthritis (RA) have been demonstrated in randomised-controlled trials.
Efficacy of fibrinolysis was demonstrated in a randomised controlled trial (RCT) and a meta-analysis [ 33, 34].
However, its efficacy has not yet been demonstrated in a randomised controlled trial using generally accepted measures.
A clinical effect on paracentesis-free survival and on the time to deterioration of QoL, has also been demonstrated in a randomised study [ 16].
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