Update to the FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical analysis plan for the trials and for the individual patient data meta-analysis

DiscussionAn IPDM of our three large trials of fluoxetine for stroke recovery will allow us to provide the most precise estimates of any risks and benefits of fluoxetine vs placebo, to detect reliably a smaller overall effect size than those detectable by the individual trials, to better determine the effects of fluoxetine vs placebo in subgroups of patients and outcomes and to broaden the generalisability of the results. Also, we may identify differences in treatment effects between studies.Trial registrationFOCUS: ISRCTNISRCTN83290762. Registered on 23 May 2012. EudraCT2011-005616-29. Registered on 3 February 2012.AFFINITY: Australian New Zealand Clinical Trials RegistryACTRN12611000774921. Registered on 22 July 2011.EFFECTS: ISRCTNISRCTN13020412. Registered on 19 December 2014. ClinicalTrials.govNCT02683213. Registered on 2 February 2016. EudraCT2011-006130-16. Registered on 8 August 2014.
Source: Trials - Category: Research Source Type: clinical trials