HRT and cardiovascular events

Was the composite outcome specified in the original protocol?

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8144 (Published 3 December 2012)
Cite this as: BMJ 2012;345:e8144

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  1. Jeppe Schroll, researcher1,
  2. Andreas Lundh, researcher1
  1. 1Nordic Cochrane Centre, 2200 Copenhagen N, Denmark
  1. js{at}cochrane.dk

It is unclear whether Schierbeck and colleagues’ primary composite outcome was defined in the original protocol.1 In other words, is their analysis exploratory or confirmatory? The main question is whether the results should lead to changes in clinical practice. Schierbeck has advocated for the safety of hormone therapy,2, but we believe that the study results …

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