REFERENCES
- Angrist , J. D. , Imbens , G. W. , Rubin , D. B. ( 1996 ). Identification of causal effects using instrumental variables . J. Am. Stat. Assoc. 91 : 444 – 456 .
- Agresti , A. ( 1990 ). Categorical Data Analysis . New York : Wiley .
- Breslow , N. E. , Day , N. E. ( 1980 ). Statistical methods in cancer research . The Analysis of Case-Control Studies . Vol. 1 . Lyon : International Agency for Research on Cancer .
- Brunner , E. , Neumann , N. ( 1985 ). On the mathematical basis of Zelen's prerandomized designs . Methods Information Med. 24 : 120 – 130 .
- Casella , G. , Berger , R. L. ( 1990 ). Statistical Inference . Belmont , CA : Duxbury .
- Cornfield , J. A. ( 1956 ). Statistical problem arising from retrospective studies . In: Neyman , J. ed. Proc. Third Berkeley Symp. Math. Stat. Prob , Vol. 4 . Berkeley : University of California Press , pp. 135 – 148 .
- Fisher , R. A. ( 1924 ). On a distribution yielding the error functions of several well known statistics . Proc. Int. Math. Congr. 2 : 805 – 813 .
- Fleiss , J. L. ( 1981 ). Statistical Methods for Rates and Proportions. , 2nd ed. New York : Wiley .
- Fleiss , J. L. ( 1986 ). The Design and Analysis of Clinical Experiments . New York : Wiley .
- Frangakis , C. E. , Rubin , D. B. ( 1999 ). Addressing complications of intention-to-treat analysis in the combined presence of all-or-none treatment-noncompliance and subsequent missing outcomes . Biometrika 86 : 365 – 379 .
- Garrett , A. D. ( 2003 ). Therapeutic equivalence: Fallacies and falsification . Stat. Med. 22 : 741 – 762 .
- Jacobson , J. M. , Spritzler , J. , Fox , L. , Fahley , J. L. , Jackson , J. B. , Chernoff , M. , Wohl , D. A. , Wu , A. W. , Hooton , T. M. , Sha , B. E. , Shikuma , C. M. , MacPhail , L. A. , Simpson , D. M. , Trapnell , C. B. , Basgoz , N. ( 1999 ). Thalidomide for the treatment of esophageal aphthour ulcers in patients with human immunodeficiency virus infection . J. Infect. Dis. 180 : 61 – 67 .
- Last , J. M. ( 1988 ). A Dictionary of Epidemiology. , 2nd ed. Oxford : Oxford University Press .
- Li , F. , Frangakis , C. E. ( 2005 ). Designs in partially controlled studies. Message from a review . Stat. Methods Med. Res. 14 : 417 – 431 .
- Lipsitz , S. R. , Dear , K. B. G. , Laird , N. M. , Molengberghs , G. ( 1998 ). Tests for homogeneity of the risk difference when data are sparse . Biometrics 54 : 148 – 160 .
- Liu , J. P. , Fan , H.-Y. , Ma , M.-C. ( 2005 ). Tests for equivalence based on odds ratio for matched-pair design . J. Biopharm. Stat. 15 : 889 – 901 .
- Lui , K.-J. (2004). Statistical Estimation of Epidemiological Risk . New York : Wiley.
- Lui , K.-J. ( 2007a ). Interval estimation of the risk difference in non-compliance randomized trials with repeated binary measurements . Stat. Med. 26 : 3140 – 3156 .
- Lui , K.-J. ( 2007b ). Estimation of proportion ratio in non-compliance randomized trials with repeated measurements in binary data . Stat. Methodol. 5 : 129 – 141 .
- Lui , K.-J. ( 2007c ). Testing homogeneity of the risk ratio in stratified noncompliance randomized trials . Contemp. Clin. Trials 28 : 614 – 625 .
- Lui , K.-J. , Kelly , C. ( 2000a ). A revisit on tests for homogeneity of the risk difference . Biometrics 56 : 309 – 315 .
- Lui , K.-J. , Kelly , C. ( 2000b ). Tests for homogeneity of the risk ratio in a series of 2 × 2 tables . Stat. Med. 19 : 2919 – 2932 .
- Lui , K.-J. , Chang , K.-C. ( 2008 ). Testing homogeneity of risk difference in stratified randomized trials with noncompliance . Comput. Stat. Data Anal. 53 : 209 – 221 .
- Mark , S. D. , Robins , J. M. ( 1993 ). A method for the analysis of randomized trials with compliance information: An application to the multiple risk factor intervention trial . Control. Clin. Trials 14 : 79 – 97 .
- Matsui , S. ( 2005 ). Stratified analysis in randomized trials with noncompliance . Biometrics 61 : 816 – 823 .
- Multiple Risk Factor Intervention Trial Research Group ( 1982 ). Multiple risk factor intervention trial: Risk factor changes and mortality results . J. Am. Med. Assoc. 248 : 1465 – 1477 .
- Nagelkerke , N. , Fidler , V. , Bernsen , R. , Borgdorff , M. ( 2000 ). Estimating treatment effects in randomized clinical trials in the presence of non-compliance . Stat. Med. 19 : 1849 – 1864 .
- Rubin , D. B. ( 1978 ). Bayesian interface for causal effects: The role of randomization . Ann. Stat. 6 : 34 – 58 .
- Rousson , V. , Seifert , B. ( 2008 ). A mixed approach for proving non-inferiority in clinical trials with binary endpoints . Biometrical J. 50 : 190 – 204 .
- SAS Institute Inc ( 1990 ). SAS Language, Reference Version 6. , 1st ed. Cary , NC : SAS Institute Inc.
- Sommer , A. , Zeger , S. L. ( 1991 ). On estimating efficacy from clinical trials . Stat. Med. 10 : 45 – 52 .
- Tu , D. ( 1998 ). On the use of the ratio or the odds ratio of cure rates in establishing therapeutic equivalence of non-systemic drugs with binary clinical endpoints . J. Biopharm. Stat. 8 : 263 – 282 .
- Tu , D. ( 2003 ). Odds ratio . In: Chow , S. C. , ed. Encyclopedia of Biopharmaceutical Statistics . New York : Taylor & Francis .
- Wang , H. , Chow , S.-C. , Li , G. ( 2002 ). On sample size calculation based on odds ratio in clinical trials . J. Biopharm. Stat. 12 : 471 – 483 .
- Whitehead , A. , Bailey , A. J. , Elbourne , D. ( 1999 ). Combining summaries of binary outcomes with those of continuous outcomes in a meta-analysis . J. Biopharm. Stat. 9 : 1 – 16 .
- Zelen , M. ( 1990 ). Randomized consent designs for clinical trials: An update . Stat. Med. 9 : 645 – 656 .
- Zhou , X.-H. , Li , S. M. ( 2006 ). ITT analysis of randomized encouragement design studies with missing data . Stat. Med. 25 : 2737 – 2761 .