References
- Brooks BR, Sufit RL, Depaul R, Tan YD, Sanjak M, Robbins J. Design of clinical therapeutic trials in ALS. Munsat TL. Advances in Neurology: Amyotrophic Lateral Sclerosis. New York: Butterworth; 1991. 521–46.
- Munsat TL. Issues in amyotrophic lateral sclerosis clinical trial design. Adv Neurol. 1995;68:209–18.
- World Federation of Neurology (WFN) Research Group on Neuromuscular Diseases Subcommittee on Motor Neuron Disease. Airlie House Guidelines. Therapeutic trials in amyotrophic lateral sclerosis. Airlie House ‘Therapeutic Trials in ALS’ Workshop Contributors. J Neurol Sci. 1995;129:1–10.
- Miller RG, Munsat TL, Swash M, Brooks BR. Consensus guidelines for the design and implementation of clinical trials in ALS. World Federation of Neurology Committee on Research. J Neurol Sci. 1999;169:2–12.
- Brinkman J, Andres P, Mendoza M, Sanjak M. Guidelines for the use and performance of quantitative outcome measures in ALS clinical trials. J Neurol Sci. 1997;147:97–111.
- Enright PL, Johnson LR, Connett JE, Voelker H, Buist AS. Spirometry in the Lung Health Study. Am Rev Respir Dis. 1991;143:1215–23.
- Malmstrom K, Peszek I, Botto A, Lu S, Enright PL, Reiss TF Botto A. Quality assurance of asthma clinical trials. Control Clin Trials. 2002;23:143–56.
- Pellegrino R, Decramer M, van Schayck CP, Dekhuijzen PN, Troosters T, van Herwaarden C, . Quality control of spirometry: a lesson from the BRONCUS trial. Eur Respir J. 2005;26:1104–9.
- Meininger V, Bensimon G, Bradley WR, Brooks B, Douillet P, Eisen AA, . Efficacy and safety of xaliproden in amyotrophic lateral sclerosis: results of two phase III trials. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5:107–17.
- American Thoracic Society Statement. Snowbird Workshop on Standardization of Spirometery. Am Rev Respir Dis. 1979;119:831–8.
- Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault J-C. Lung volume and forced ventilatory flows. Report of Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J. 1993;6 (Suppl 6):5–40.
- Standardization of Spirometery. Update Respir Care. 1987;32:1039–51.
- Cook RD. Detection of influential observations in linear regression. Technometrics. 1977;19:15–8.
- ALS CNTF Treatment Study Group. A double-blind placebo-controlled clinical trial of subcutaneous recombinant human ciliary neurotrophic factor (rHCNTF) in amyotrophic lateral sclerosis. Neurology. 1996;46: 1244.
- Lai EC, Felice KJ, Festoff BW, Gawel MJ, Gelinas DF, Kratz R, et al . Effect of recombinant human insulin-like growth factor-1 on progression of ALS: a placebo-controlled study. The North America ALS/IGF-I Study Group. Neurology. 1997;49:1621–30.
- Bradley WG, Miller RG, and the BDNF Study Group (phase III). Phase III trial of subcutaneous recombinant human BDNF in patients with amyotrophic lateral sclerosis. Neurology. 1999;52:1427–33.
- Cudkowicz ME, Shefner JM, Schoenfeld DA, Brown RH Jr, Johnson H, Qureshi M, . A randomized, placebo-controlled trial of topiramate in amyotrophic lateral sclerosis. Neurology. 2003; 61:456–64.
- Lyall RA, Donaldson N, Polkey MI, Leigh PN, Moxham J. Respiratory muscle strength and ventilatory failure in amyotrophic lateral sclerosis. Brain. 2001;124:2000–13.
- Meininger V, Bensimon G, Lacomblez L, Salachas F. Natural history of amyotrophic lateral sclerosis. Serratrice G, Munsat T. Pathogenesis and Therapy of Amyotrophic Lateral Sclerosis, Advances in Neurology, vol. 28. Philadelphia: Lippincott-Raven Publishers; 1995. 199–207.