Johansen PP, Zwisler A-D, HastrupSvendsen J, et al. The CopenHeartSF trial— comprehensive sexual rehabilitation programme for male patients with implantable cardioverter defibrillator or ischaemic heart disease and impaired sexual function: protocol of a randomised clinical trial. BMJ Open 2013;3:e003967.
There has been an update to the Statistical Analyses Plan. The new Statistical Analysis section should read:
Statistical analysis
The analysis will follow the intention-to-treat principle with two-sided significance test at the 5% level. Continuous outcomes will follow the same procedure as described in the following for the primary outcome. The primary outcome is the International Index of Erectile Function overall score. The five domains of the questionnaire are all exploratory outcome, but particular attention is given the Erectile Function domain. The secondary outcome is PAIS-SR sexual relationship domain.
The explorative physical outcomes are pelvic floor strength and endurance (one categorical and two continuous variables), peak VO2, heart...
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