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An obstacle when bringing the pre-clinical finding to the clinic may be that the analgesic trial needs to include a high number of patients in order to reach statistical significance.[23] This is due to the subjective nature of the pain experience, which means that pain levels often differ greatly between individuals. However, the inability to distinguish two different treatments may in fact represent an artefact of the statistical approach, as previously suggested by Shafer and Struys.[24] The important advantage of using a non-linear mixed-effects http://www.selleckchem.com/products/ch5424802.html approach for the data analysis is that the method separates the intersubject variability from the residual random error (i.e., the difference between model prediction and the corresponding observation).[24] Hence, an actual treatment effect, although hidden by high variability between individuals, http://www.selleckchem.com/products/VX-770.html may be detected once the variability is properly factored in.[25] The present study aimed to provide an initial proof of concept for adding donepezil to existing gabapentin treatment in patients with neuropathic pain caused by surgery or trauma. It was hypothesised that an eventual pain-relieving effect of the drug combination was detectable (although not statistically significant) in a small group ( http://www.selleck.cn/products/Verteporfin(Visudyne).html medication to gabapentin. The usefulness of mixed-effects analysis is also demonstrated in the study. This open-label study was designed as an exploratory study with a mixed-effects statistical approach and approved by the Swedish Medical Products Agency (EudraCT Number: 2009-010783-41) and the Regional Ethical Review Board in Uppsala (EPN Number 2009/126, approved 6 July 2009). The trial was registered with http://www.ClinicalTrials.gov (NCT00967707) before enrolment and conducted in accordance with Good Clinical Practice and the Declaration of Helsinki. The study was conducted at the Multidisciplinary Pain Centre at Uppsala University Hospital in Sweden from September 2009 to August 2011. The original study also included a second treatment arm investigating add-on treatment with venlafaxine, an antidepressant of the selective serotonin-noradrenaline class (see Fig.?1). Patients were randomised to either the gabapentin-donepezil or the gabapentin-venlafaxine arm upon inclusion.