covariate_adjustment.bib

%%% OUR REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{VanLancker2022,
  doi = {10.48550/ARXIV.2201.12921},
  url = {https://arxiv.org/abs/2201.12921},
  author = {Van Lancker,  Kelly and Betz,  Joshua and Rosenblum,  Michael},
  keywords = {Methodology (stat.ME),  FOS: Computer and information sciences,  FOS: Computer and information sciences},
  title = {Combining Covariate Adjustment with Group Sequential,  Information Adaptive Designs to Improve Randomized Trial Efficiency},
  journal={arXiv preprint arXiv:1409.0473},
  publisher = {arXiv},
  year = {2022},
  copyright = {Creative Commons Attribution 4.0 International}
}




%%% R PACKAGE REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@Manual{boot_package,
    title = {boot: Bootstrap R (S-Plus) Functions},
    author = {Angelo Canty and B. D. Ripley},
    year = {2022},
    note = {R package version 1.3-28.1},
    url = {https://cran.r-project.org/web/packages/boot/}
  }
  
@Manual{margins_package,
    title = {margins: Marginal Effects for Model Objects},
    author = {Thomas J. Leeper},
    year = {2021},
    note = {R package version 0.3.26},
    url = {https://cran.r-project.org/web/packages/margins}
  }
  
@Manual{rpact_package,
    title = {rpact: Confirmatory Adaptive Clinical Trial Design and Analysis},
    author = {Gernot Wassmer and Friedrich Pahlke},
    year = {2023},
    note = {R package version 3.4.0},
    url = {https://CRAN.R-project.org/web/packages/rpact},
  }
  
@article{Zeileis2006,
  doi = {10.18637/jss.v016.i09},
  url = {https://doi.org/10.18637/jss.v016.i09},
  year = {2006},
  publisher = {Foundation for Open Access Statistic},
  volume = {16},
  number = {9},
  author = {Achim Zeileis},
  title = {Object-Oriented Computation of Sandwich Estimators},
  journal = {Journal of Statistical Software}
}




%%% CLINICAL TRIALS REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Assmann2000,
  doi = {10.1016/s0140-6736(00)02039-0},
  url = {https://doi.org/10.1016/s0140-6736(00)02039-0},
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  publisher = {Elsevier {BV}},
  volume = {355},
  number = {9209},
  pages = {1064--1069},
  author = {Susan F Assmann and Stuart J Pocock and Laura E Enos and Linda E Kasten},
  title = {Subgroup analysis and other (mis)uses of baseline data in clinical trials},
  journal = {The Lancet}
}

@article{Schulz2010,
  doi = {10.1136/bmj.c332},
  url = {https://doi.org/10.1136/bmj.c332},
  year = {2010},
  month = mar,
  publisher = {{BMJ}},
  volume = {340},
  number = {mar23 1},
  pages = {c332--c332},
  author = {K. F Schulz and D. G Altman and D. Moher and},
  title = {{CONSORT} 2010 Statement: updated guidelines for reporting parallel group randomised trials},
  journal = {{BMJ}}
}

@article{Gamble2017,
  doi = {10.1001/jama.2017.18556},
  url = {https://doi.org/10.1001/jama.2017.18556},
  year = {2017},
  month = dec,
  publisher = {American Medical Association ({AMA})},
  volume = {318},
  number = {23},
  pages = {2337},
  author = {Carrol Gamble and Ashma Krishan and Deborah Stocken and Steff Lewis and Edmund Juszczak and Caroline Dor{\'{e}} and Paula R. Williamson and Douglas G. Altman and Alan Montgomery and Pilar Lim and Jesse Berlin and Stephen Senn and Simon Day and Yolanda Barbachano and Elizabeth Loder},
  title = {Guidelines for the Content of Statistical Analysis Plans in Clinical Trials},
  journal = {{JAMA}}
}




%%% INFORMATION MONITORING REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Mehta2001,
  title = {Flexible Sample Size Considerations Using Information-Based Interim Monitoring},
  volume = {35},
  ISSN = {2164-9200},
  url = {http://dx.doi.org/10.1177/009286150103500407},
  DOI = {10.1177/009286150103500407},
  number = {4},
  journal = {Drug Information Journal},
  publisher = {Springer Science and Business Media LLC},
  author = {Mehta,  Cyrus R. and Tsiatis,  Anastasios A.},
  year = {2001},
  month = oct,
  pages = {1095–1112}
}




%%% GROUP SEQUENTIAL DESIGNS REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@book{Jennison1999,
  doi = {10.1201/9780367805326},
  url = {https://doi.org/10.1201/9780367805326},
  year = {1999},
  month = sep,
  publisher = {Chapman and Hall/{CRC}},
  author = {Christopher Jennison and Bruce W. Turnbull},
  title = {Group Sequential Methods with Applications to Clinical Trials}
}




%%% STRATIFIED RANDOMIZATION REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Kahan2011,
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  title = {Improper analysis of trials randomised using stratified blocks or minimisation},
  journal = {Statistics in Medicine}
}

@article{Kernan1999,
  doi = {10.1016/s0895-4356(98)00138-3},
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  month = jan,
  publisher = {Elsevier {BV}},
  volume = {52},
  number = {1},
  pages = {19--26},
  author = {W Kernan},
  title = {Stratified Randomization for Clinical Trials},
  journal = {Journal of Clinical Epidemiology}
}

@article{Lin2015,
  doi = {10.1016/j.cct.2015.07.011},
  url = {https://doi.org/10.1016/j.cct.2015.07.011},
  year = {2015},
  month = nov,
  publisher = {Elsevier {BV}},
  volume = {45},
  pages = {21--25},
  author = {Yunzhi Lin and Ming Zhu and Zheng Su},
  title = {The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials},
  journal = {Contemporary Clinical Trials}
}

@article{Wang2021,
  doi = {10.1080/01621459.2021.1981338},
  url = {https://doi.org/10.1080/01621459.2021.1981338},
  year = {2021},
  month = nov,
  publisher = {Informa {UK} Limited},
  volume = {118},
  number = {542},
  pages = {1152--1163},
  author = {Bingkai Wang and Ryoko Susukida and Ramin Mojtabai and Masoumeh Amin-Esmaeili and Michael Rosenblum},
  title = {Model-Robust Inference for Clinical Trials that Improve Precision by Stratified Randomization and Covariate Adjustment},
  journal = {Journal of the American Statistical Association}
}




%%% SURVEYS OF COVARIATE ADJUSTMENT IN PRACTICE %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Austin2010,
  doi = {10.1016/j.jclinepi.2009.06.002},
  url = {https://doi.org/10.1016/j.jclinepi.2009.06.002},
  year = {2010},
  month = feb,
  publisher = {Elsevier {BV}},
  volume = {63},
  number = {2},
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  author = {Peter C. Austin and Andrea Manca and Merrick Zwarenstein and David N. Juurlink and Matthew B. Stanbrook},
  title = {A substantial and confusing variation exists in handling of baseline covariates in randomized controlled trials: a review of trials published in leading medical journals},
  journal = {Journal of Clinical Epidemiology}
}

@article{Pocock2002,
  doi = {10.1002/sim.1296},
  url = {https://doi.org/10.1002/sim.1296},
  year = {2002},
  publisher = {Wiley},
  volume = {21},
  number = {19},
  pages = {2917--2930},
  author = {Stuart J. Pocock and Susan E. Assmann and Laura E. Enos and Linda E. Kasten},
  title = {Subgroup analysis,  covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems},
  journal = {Statistics in Medicine}
}




%%% REVIEW ARTICLES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Benkeser2020,
  doi = {10.1111/biom.13377},
  url = {https://doi.org/10.1111/biom.13377},
  year = {2020},
  month = oct,
  publisher = {Wiley},
  volume = {77},
  number = {4},
  pages = {1467--1481},
  author = {David Benkeser and Iv{\'{a}}n D{\'{\i}}az and Alex Luedtke and Jodi Segal and Daniel Scharfstein and Michael Rosenblum},
  title = {Improving precision and power in randomized trials for {COVID}-19 treatments using covariate adjustment,  for binary,  ordinal,  and time-to-event outcomes},
  journal = {Biometrics}
}




%%% COMPARING ESTIMATORS %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Colantuoni2015,
  doi = {10.1002/sim.6507},
  url = {https://doi.org/10.1002/sim.6507},
  year = {2015},
  month = apr,
  publisher = {Wiley},
  volume = {34},
  number = {18},
  pages = {2602--2617},
  author = {Elizabeth Colantuoni and Michael Rosenblum},
  title = {Leveraging prognostic baseline variables to gain precision in randomized trials},
  journal = {Statistics in Medicine}
}




%%% CONTINUOUS OUTCOMES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Tsiatis2008,
  doi = {10.1002/sim.3113},
  url = {https://doi.org/10.1002/sim.3113},
  year = {2008},
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  pages = {4658--4677},
  author = {Anastasios A. Tsiatis and Marie Davidian and Min Zhang and Xiaomin Lu},
  title = {Covariate adjustment for two-sample treatment comparisons in randomized clinical trials: A principled yet flexible approach},
  journal = {Statistics in Medicine}
}

@article{Jiang2019,
  doi = {10.1080/01621459.2018.1527226},
  url = {https://doi.org/10.1080/01621459.2018.1527226},
  year = {2019},
  month = mar,
  publisher = {Informa {UK} Limited},
  volume = {114},
  number = {528},
  pages = {1854--1864},
  author = {Fei Jiang and Lu Tian and Haoda Fu and Takahiro Hasegawa and L. J. Wei},
  title = {Robust Alternatives to {ANCOVA} for Estimating the Treatment Effect via a Randomized Comparative Study},
  journal = {Journal of the American Statistical Association}
}

@article{Zhang2008,
  doi = {10.1111/j.1541-0420.2007.00976.x},
  url = {https://doi.org/10.1111/j.1541-0420.2007.00976.x},
  year = {2008},
  month = jan,
  publisher = {Wiley},
  volume = {64},
  number = {3},
  pages = {707--715},
  author = {Min Zhang and Anastasios A. Tsiatis and Marie Davidian},
  title = {Improving Efficiency of Inferences in Randomized Clinical Trials Using Auxiliary Covariates},
  journal = {Biometrics}
}




%%% BINARY OUTCOMES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Ge2011,
  doi = {10.1177/009286151104500409},
  url = {https://doi.org/10.1177/009286151104500409},
  year = {2011},
  month = jul,
  publisher = {Springer Science and Business Media {LLC}},
  volume = {45},
  number = {4},
  pages = {481--493},
  author = {Miaomiao Ge and L. Kathryn Durham and R. Daniel Meyer and Wangang Xie and Neal Thomas},
  title = {Covariate-Adjusted Difference in Proportions from Clinical Trials Using Logistic Regression and Weighted Risk Differences},
  journal = {Drug Information Journal}
}

@article{Moore2009_stat_med,
  doi = {10.1002/sim.3445},
  url = {https://doi.org/10.1002/sim.3445},
  year = {2009},
  month = jan,
  publisher = {Wiley},
  volume = {28},
  number = {1},
  pages = {39--64},
  author = {K. L. Moore and M. J. van der Laan},
  title = {Covariate adjustment in randomized trials with binary outcomes: Targeted maximum likelihood estimation},
  journal = {Statistics in Medicine}
}

@article{Steingrimsson2017,
  doi = {10.1016/j.cct.2016.12.026},
  url = {https://doi.org/10.1016/j.cct.2016.12.026},
  year = {2017},
  month = mar,
  publisher = {Elsevier {BV}},
  volume = {54},
  pages = {18--24},
  author = {Jon Arni Steingrimsson and Daniel F. Hanley and Michael Rosenblum},
  title = {Improving precision by adjusting for prognostic baseline variables in randomized trials with binary outcomes,  without regression model assumptions},
  journal = {Contemporary Clinical Trials}
}




%%% ORDINAL OUTCOMES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Diaz2015,
  doi = {10.1111/biom.12450},
  url = {https://doi.org/10.1111/biom.12450},
  year = {2015},
  month = nov,
  publisher = {Wiley},
  volume = {72},
  number = {2},
  pages = {422--431},
  author = {Iv{\'{a}}n D{\'{\i}}az and Elizabeth Colantuoni and Michael Rosenblum},
  title = {Enhanced precision in the analysis of randomized trials with ordinal outcomes},
  journal = {Biometrics}
}

@article{Fay2018,
  doi = {10.1002/sim.7890},
  url = {https://doi.org/10.1002/sim.7890},
  year = {2018},
  month = jul,
  publisher = {Wiley},
  volume = {37},
  number = {27},
  pages = {3991--4006},
  author = {Michael P. Fay and Yaakov Malinovsky},
  title = {Confidence intervals of the Mann-Whitney parameter that are compatible with the Wilcoxon-Mann-Whitney test},
  journal = {Statistics in Medicine}
}

@article{Vermeulen2014,
  doi = {10.1002/sim.6386},
  url = {https://doi.org/10.1002/sim.6386},
  year = {2014},
  month = dec,
  publisher = {Wiley},
  volume = {34},
  number = {6},
  pages = {1012--1030},
  author = {Karel Vermeulen and Olivier Thas and Stijn Vansteelandt},
  title = {Increasing the power of the Mann-Whitney test in randomized experiments through flexible covariate adjustment},
  journal = {Statistics in Medicine}
}

@article{Zhao2008,
  doi = {10.1002/sim.2912},
  url = {https://doi.org/10.1002/sim.2912},
  year = {2008},
  publisher = {Wiley},
  volume = {27},
  number = {3},
  pages = {462--468},
  author = {Yan D. Zhao and Dewi Rahardja and Yongming Qu},
  title = {Sample size calculation for the Wilcoxon{\textendash}Mann{\textendash}Whitney test adjusting for ties},
  journal = {Statistics in Medicine}
}




%%% TIME TO EVENT %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Brooks2013,
  doi = {10.1515/jci-2013-0001},
  url = {https://doi.org/10.1515/jci-2013-0001},
  year = {2013},
  month = nov,
  publisher = {Walter de Gruyter {GmbH}},
  volume = {1},
  number = {2},
  pages = {235--254},
  author = {Jordan C. Brooks and Mark J. van der Laan and Daniel E. Singer and Alan S. Go},
  title = {Targeted Minimum Loss-Based Estimation of Causal Effects in Right-Censored Survival Data with Time-Dependent Covariates: Warfarin,  Stroke,  and Death in Atrial Fibrillation},
  journal = {Journal of Causal Inference}
}

@article{Lin2017,
  doi = {10.1016/j.conctc.2017.09.004},
  url = {https://doi.org/10.1016/j.conctc.2017.09.004},
  year = {2017},
  month = dec,
  publisher = {Elsevier {BV}},
  volume = {8},
  pages = {147--155},
  author = {Ray S. Lin and Larry F. Le{\'{o}}n},
  title = {Estimation of treatment effects in weighted log-rank tests},
  journal = {Contemporary Clinical Trials Communications}
}

@article{Moore2009_j_biopharm_stat,
  doi = {10.1080/10543400903243017},
  url = {https://doi.org/10.1080/10543400903243017},
  year = {2009},
  month = oct,
  publisher = {Informa {UK} Limited},
  volume = {19},
  number = {6},
  pages = {1099--1131},
  author = {K. L. Moore and M. J. van der Laan},
  title = {Increasing Power in Randomized Trials with Right Censored Outcomes Through Covariate Adjustment},
  journal = {Journal of Biopharmaceutical Statistics}
}

@article{Parast2014,
  doi = {10.1080/01621459.2013.842488},
  url = {https://doi.org/10.1080/01621459.2013.842488},
  year = {2014},
  month = jan,
  publisher = {Informa {UK} Limited},
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  author = {Layla Parast and Lu Tian and Tianxi Cai},
  title = {Landmark Estimation of Survival and Treatment Effect in a Randomized Clinical Trial},
  journal = {Journal of the American Statistical Association}
}

@article{Stitelman2012,
  doi = {10.1515/1557-4679.1334},
  url = {https://doi.org/10.1515/1557-4679.1334},
  year = {2012},
  month = jan,
  publisher = {Walter de Gruyter {GmbH}},
  volume = {8},
  number = {1},
  author = {Ori M. Stitelman and Victor De Gruttola and Mark J. van der Laan},
  title = {A General Implementation of {TMLE} for Longitudinal Data Applied to Causal Inference in Survival Analysis},
  journal = {The International Journal of Biostatistics}
}




%%% RESTRICTED MEAN SURVIVAL TIME %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Chen2001,
  doi = {10.1111/j.0006-341x.2001.01030.x},
  url = {https://doi.org/10.1111/j.0006-341x.2001.01030.x},
  year = {2001},
  month = dec,
  publisher = {Wiley},
  volume = {57},
  number = {4},
  pages = {1030--1038},
  author = {Pei-Yun Chen and Anastasios A. Tsiatis},
  title = {Causal Inference on the Difference of the Restricted Mean Lifetime Between Two Groups},
  journal = {Biometrics}
}

@article{Diaz2018,
  doi = {10.1007/s10985-018-9428-5},
  url = {https://doi.org/10.1007/s10985-018-9428-5},
  year = {2018},
  month = feb,
  publisher = {Springer Science and Business Media {LLC}},
  volume = {25},
  number = {3},
  pages = {439--468},
  author = {Iv{\'{a}}n D{\'{\i}}az and Elizabeth Colantuoni and Daniel F. Hanley and Michael Rosenblum},
  title = {Improved precision in the analysis of randomized trials with survival outcomes,  without assuming proportional hazards},
  journal = {Lifetime Data Analysis}
}

@article{DiRienzo2001,
  doi = {10.1111/1467-9868.00310},
  url = {https://doi.org/10.1111/1467-9868.00310},
  year = {2001},
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  number = {4},
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  author = {A. G. DiRienzo and S. W. Lagakos},
  title = {Effects of model misspecification on tests of no randomized treatment effect arising from Cox{\textquotesingle}s proportional hazards model},
  journal = {Journal of the Royal Statistical Society: Series B (Statistical Methodology)}
}

@article{Eaton2020,
  title = {Designing clinical trials with (restricted) mean survival time endpoint: Practical considerations},
  volume = {17},
  ISSN = {1740-7753},
  url = {http://dx.doi.org/10.1177/1740774520905563},
  DOI = {10.1177/1740774520905563},
  number = {3},
  journal = {Clinical Trials},
  publisher = {SAGE Publications},
  author = {Eaton,  Anne and Therneau,  Terry and Le-Rademacher,  Jennifer},
  year = {2020},
  month = feb,
  pages = {285--294}
}




%%% SANDWICH REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Long2000,
  doi = {10.1080/00031305.2000.10474549},
  url = {https://doi.org/10.1080/00031305.2000.10474549},
  year = {2000},
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  pages = {217--224},
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  title = {Using Heteroscedasticity Consistent Standard Errors in the Linear Regression Model},
  journal = {The American Statistician}
}

@article{Zeileis2004,
  doi = {10.18637/jss.v011.i10},
  url = {https://doi.org/10.18637/jss.v011.i10},
  year = {2004},
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  volume = {11},
  number = {10},
  author = {Achim Zeileis},
  title = {Econometric Computing with {HC} and {HAC} Covariance Matrix Estimators},
  journal = {Journal of Statistical Software}
}

@article{Ye2023,
  title = {Robust variance estimation for covariate-adjusted unconditional treatment effect in randomized clinical trials with binary outcomes},
  volume = {7},
  ISSN = {2475-4277},
  url = {http://dx.doi.org/10.1080/24754269.2023.2205802},
  DOI = {10.1080/24754269.2023.2205802},
  number = {2},
  journal = {Statistical Theory and Related Fields},
  publisher = {Informa UK Limited},
  author = {Ye,  Ting and Bannick,  Marlena and Yi,  Yanyao and Shao,  Jun},
  year = {2023},
  month = apr,
  pages = {159--163}
}




%%% BOOTSTRAP REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@Book{Davidson1997,
    title = {Bootstrap Methods and Their Applications},
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  }

@book{Efron1994,
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}

@article{Efron1987,
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  journal = {Journal of the American Statistical Association}
}

@article{DiCiccio1996,
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  journal = {Statistical Science}
}




%%% GENERALIZED LINEAR MODELS %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@book{DobsonBarnett2018,
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  year = {2018},
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  title = {An Introduction to Generalized Linear Models,  Fourth Edition}
}

@article{McCullagh1980,
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  title = {Regression Models for Ordinal Data},
  journal = {Journal of the Royal Statistical Society: Series B (Methodological)}
}




%%% MISTIE III EXAMPLE %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Hanley2019,
  doi = {10.1016/s0140-6736(19)30195-3},
  url = {https://doi.org/10.1016/s0140-6736(19)30195-3},
  year = {2019},
  month = mar,
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@article{Chaisinanunkul2015,
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}




%%% CTN-0003 EXAMPLE REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Ling2009,
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  title = {Buprenorphine tapering schedule and illicit opioid use},
  journal = {Addiction}
}




%%% CTN-030 EXAMPLE REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

@article{Campbell2014,
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}