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1242  The Journal of Pain                                           Cannabis for the Management of Pain
            improvements in these efficacy measures resulted from  and should be extended to allow estimation of
            regression to the mean, natural history of disease or  longer-term risks.
            the effect of being in the study. However, these biases
            would apply to both groups, yet still we noted difference  Acknowledgments
            between groups.
              Despite these limitations, this study improves our  We gratefully acknowledge the support and contri-
                                                              butions of Anna Passariello, Nicole Poitras, and Linda
            knowledge about the safety of medical cannabis.
            Caution should be exercised in interpreting these results  Fergsuon (study coordinators); Ann Robinson (study
            for all medical cannabis use as patients in this study used  monitor); Randa Zamrini (data manager); Myrna Yazer,
                                                              Sylvie Toupin, Ann Rusnov, Charlene Bartha, Marilyn
            a standardized, quality-controlled herbal cannabis prod-
            uct with a reliable THC potency of 12.5%.         Galonski, Selena Roy, Susan Brophy, Joanne Stewart
                                                              (study nurses); Thierry Ducruet (statistical support); Pe-
              In conclusion, this study suggests that the AEs of
            medical cannabis are modest and comparable quanti-  ter Fried (neuropsychiatry consultant); Don Boudreau
                                                              (pulmonology consultant); Kam Shojania (rheuma-
            tatively and qualitatively with prescription cannabi-
            noids. The results suggest that cannabis at average  tology), and all the patients who made the study
                                                              possible.
            doses of 2.5 g/d in current cannabis users may be
            safe as part of a carefully monitored pain manage-  Safety Monitoring Advisory Committee.
                                                                Robin O’Brien (chair), Lawrence Joseph, Jock Murray.
            ment program when conventional treatments have
            been considered medically inappropriate or inade-   Adverse Event Adjudication Committee.
            quate. However, safety concerns in naive users      Mark Ware, Mary Lynch.
            cannot be addressed. Moreover, long-term effects
            on pulmonary functions and neurocognitive func-   Supplementary data
            tions beyond 1 year cannot be determined. Further
            studies with systematic follow-up are required to   Supplementary data related to this article can be
            characterize safety issues among new cannabis users  found at http://dx.doi.org/10.1016/j.jpain.2015.07.014.


            References                                        10. SAS Institute: SAS/STAT User’s Guide, version 9. Cary, NC,
                                                              SAS Institute, 2007

            1. Abrams DI,Jay CA,Shade SB,Vizoso H, RedaH,     11. Solowij N, Stephens RS, Roffman RA, Babor T, Kadden R,
            Press  S,  Kelly  ME,  Rowbotham  MC,  Petersen  KL:  Miller M, Christiansen K, McRee B, Vendetti J: Cognitive
            Cannabis in painful HIV-associated sensory neuropathy:  functioning of long-term heavy cannabis users seeking
            a randomized placebo-controlled trial. Neurology 68:  treatment. JAMA 287:1123-1131, 2002
            515-521, 2007
                                                              12. Tashkin DP: Effects of marijuana smoking on the lung.
            2. Agresti A: Categorical Data Analysis, 2nd ed. Hoboken,  Ann Am Thorac Soc 10:239-247, 2013
            NJ, John Wiley, 2002
                                                              13. The use of the WHO-UMC system for standardised case
            3. Common terminology criteria for adverse events v3.0.  causality assessment. Available at: http://who-umc.org/
            Available at: http://ctep.cancer.gov/protocolDevelopment/  Graphics/24734.pdf. Accessed July 25, 2013.
            electronic_applications/docs/ctcaev3.pdf. Accessed July 25,
            2013                                              14. Wade DT, Makela PM, House H, Bateman C, Robson P:
                                                              Long-term use of a cannabis-based medicine in the treat-
            4. Corey-Bloom J, Wolfson T, Gamst A, Jin S, Marcotte TD,  ment of spasticity and other symptoms in multiple sclerosis.
            Bentley H, Gouaux B: Smoked cannabis for spasticity in mul-  Mult Scler 12:639-645, 2006
            tiple sclerosis: a randomized, placebo-controlled trial. CMAJ
            184:1143-1150, 2012                               15. Walker AM, Stampfer MJ: Observational studies of drug
                                                              safety. Lancet 348:489, 1996
            5. Gardner W, Mulvey EP, Shaw EC: Regression analyses
            of counts and rates: Poisson, overdispersed Poisson,  16. Wang T, Collet JP, Shapiro S, Ware MA: Adverse effects
            and  negative  binomial  models.  Psychol  Bull  118:  of medical cannabinoids: a systematic review. CMAJ 178:
            392-404, 1995                                     1669-1678, 2008
            6. Grant I, Gonzalez R, Carey CL, Natarajan L, Wolfson T:  17. Ware MA, Wang T, Shapiro S, Robinson A, Ducruet T,
            Non-acute (residual) neurocognitive effects of cannabis  Huynh T, Gamsa A, Bennett GJ, Collet JP: Smoked cannabis
            use: a meta-analytic study. J Int Neuropsychol Soc 9:  for chronic neuropathic pain: a randomized controlled trial.
            679-689, 2003                                     CMAJ 182:E694-E701, 2010

            7. Hall W, Degenhardt L: Adverse health effects of non-  18. Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H,
            medical cannabis use. Lancet 374:1383-1391, 2009  Gouaux B, Fishman S: A randomized, placebo-controlled,
                                                              crossover trial of cannabis cigarettes in neuropathic pain. J
            8. Health Canada. Marihuana for medical purposes regula-  Pain 9:506-521, 2008
            tions.  Available  at:  http://gazette.gc.ca/rp-pr/p2/2013/
            2013-06-19/html/sor-dors119-eng.php.Accessed May 14,2014  19. Zajicek JP, Sanders HP, Wright DE, Vickery PJ,
                                                              Ingram WM, Reilly SM, Nunn AJ, Teare LJ, Fox PJ,
            9. ICH: Definitions and standards for expedited reporting.  Thompson AJ: Cannabinoids in multiple sclerosis (CAMS)
            Available at: http://www.ich.org/cache/compo/276-254-1.  study: safety and efficacy data for 12 months follow up. J
            html. Accessed October 1, 2005                    Neurol Neurosurg Psychiatry 76:1664-1669, 2005
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