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  author={Franklin, Jessica and Patorno, Elisabetta and Desai, Rishi and Glynn, Robert and Martin, David and Quinto, Kenneth and Pawar, Ajinkya and Bessette, Lily and Lee, Hemin and Garry, Elizabeth and others},
  journal={Circulation},
  volume={143},
  number={10},
  pages={1002--1013},
  year={2021},
  publisher={Am Heart Assoc}
}

@techreport{lei2021distribution,
  title={Distribution-free assessment of population overlap in observational studies},
  author={Lei, Lihua and D’Amour, Alexander and Ding, Peng and Feller, Avi and Sekhon, Jasjeet},
  year={2021},
  institution={Working paper, Stanford University}
}

@article{kern2016assessing,
  title={Assessing methods for generalizing experimental impact estimates to target populations},
  author={Kern, Holger L and Stuart, Elizabeth A and Hill, Jennifer and Green, Donald P},
  journal={Journal of Research on Educational Effectiveness},
  volume={9},
  number={1},
  pages={103--127},
  year={2016},
  publisher={Taylor \& Francis}
}

@article{jin2023sensitivity,
  title={Sensitivity analysis of individual treatment effects: A robust conformal inference approach},
  author={Jin, Ying and Ren, Zhimei and Cand{\`e}s, Emmanuel J},
  journal={Proceedings of the National Academy of Sciences},
  volume={120},
  number={6},
  pages={e2214889120},
  year={2023},
  publisher={National Acad Sciences}
}

@article{hartman2021generalizing,
  title={Generalizing experimental results},
  author={Hartman, Erin and Druckman, James and Green, Donald},
  journal={Advances in Experimental Political Science},
  volume={385},
  year={2021},
  publisher={Cambridge University Press Cambridge}
}

@article{d2021overlap,
  title={Overlap in observational studies with high-dimensional covariates},
  author={D’Amour, Alexander and Ding, Peng and Feller, Avi and Lei, Lihua and Sekhon, Jasjeet},
  journal={Journal of Econometrics},
  volume={221},
  number={2},
  pages={644--654},
  year={2021},
  publisher={Elsevier}
}

@article{vandenbroucke2009hrt,
  title={The {HRT} controversy: observational studies and {RCT}s fall in line},
  author={Vandenbroucke, Jan},
  journal={The Lancet},
  volume={373},
  number={9671},
  pages={1233--1235},
  year={2009},
  publisher={Elsevier}
}


@article{hussain2022falsification,
  title={Falsification before Extrapolation in Causal Effect Estimation},
  author={Hussain, Zeshan and Oberst, Michael and Shih, Ming-Chieh and Sontag, David},
  journal={Advances in Neural Information Processing Systems},
  year={2022}
}

@article{crump2009dealing,
  title={Dealing with limited overlap in estimation of average treatment effects},
  author={Crump, Richard K and Hotz, V Joseph and Imbens, Guido W and Mitnik, Oscar A},
  journal={Biometrika},
  volume={96},
  number={1},
  pages={187--199},
  year={2009},
  publisher={Oxford University Press}
}

@article{yadlowsky2022bounds,
  title={Bounds on the conditional and average treatment effect with unobserved confounding factors},
  author={Yadlowsky, Steve and Namkoong, Hongseok and Basu, Sanjay and Duchi, John and Tian, Lu},
  journal={The Annals of Statistics},
  volume={50},
  number={5},
  pages={2587--2615},
  year={2022},
  publisher={Institute of Mathematical Statistics}
}

@article{yangelastic,
    author = {Yang, Shu and Gao, Chenyin and Zeng, Donglin and Wang, Xiaofei},
    title = "{Elastic integrative analysis of randomised trial and real-world data for treatment heterogeneity estimation}",
    journal = {Journal of the Royal Statistical Society Series B: Statistical Methodology},
    volume = {85},
    number = {3},
    pages = {575-596},
    year = {2023},
    month = {04},
    abstract = "{We propose a test-based elastic integrative analysis of the randomised trial and real-world data to estimate treatment effect heterogeneity with a vector of known effect modifiers. When the real-world data are not subject to bias, our approach combines the trial and real-world data for efficient estimation. Utilising the trial design, we construct a test to decide whether or not to use real-world data. We characterise the asymptotic distribution of the test-based estimator under local alternatives. We provide a data-adaptive procedure to select the test threshold that promises the smallest mean square error and an elastic confidence interval with a good finite-sample coverage property.}",    
       eprint = {https://academic.oup.com/jrsssb/article-pdf/85/3/575/50859810/qkad017.pdf},
}

@article{yang2020improved,
  title={Improved inference for heterogeneous treatment effects using real-world data subject to hidden confounding},
  author={Yang, Shu and Zeng, Donglin and Wang, Xiaofei},
  journal={arXiv preprint arXiv:2007.12922},
  year={2020}
}
@article{rothwell2005external,
  title={External validity of randomised controlled trials:“to whom do the results of this trial apply?”},
  author={Rothwell, Peter },
  journal={The Lancet},
  volume={365},
  number={9453},
  pages={82--93},
  year={2005},
  publisher={Elsevier}
}

@article{wu2022integrative,
  title = 	 {Integrative \text{R}-learner of heterogeneous treatment effects combining experimental and observational studies},
  author =       {Wu, Lili and Yang, Shu},
  journal = 	 {Conference on Causal Learning and Reasoning},
  year = 	 {2022},
  abstract = 	 {The gold-standard approach to estimating heterogeneous treatment effects (HTEs) is randomized controlled trials (RCTs)/controlled experimental studies, where treatment randomization mitigates confounding biases. However, experimental data are usually small in sample size and limited in subjects’ diversity due to expensive costs. On the other hand, large observational studies (OSs) are becoming increasingly popular and accessible. However, OSs might be subject to hidden confounding whose existence is not testable. We develop an integrative $R$-learner for the HTE and confounding function by leveraging experimental data for identification and observational data for boosting efficiency. We form a regularized loss function for the HTE and confounding function that bears the Neyman orthogonality property, allowing flexible models for the nuisance function estimation. The key novelty of the proposed integrative $R$-learner is to impose different regularization terms for the HTE and confounding function so that the possible smoothness or sparsity of the confounding function can be leveraged to improve the HTE estimation. Our integrative $R$-learner has two benefits: first, it provides a general framework that can accommodate various HTE models for loss minimization; second, without any prior knowledge of hidden confounding in the OS, the proposed integrative $R$-learner is consistent and asymptotically at least as efficient as the estimator using only the RCT. The experiments based on extensive simulation and a real-data application adapted from an educational experiment show that the proposed integrative $R$-learner outperforms alternative approaches. }
}



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  title={Sensitivity analysis in observational research: introducing the E-value},
  author={VanderWeele, Tyler and Ding, Peng},
  journal={Annals of Internal Medicine},
  volume={167},
  number={4},
  pages={268--274},
  year={2017},
  publisher={American College of Physicians}
}

@article{dagan2021bnt162b2,
  title={{BNT162b2 mRNA Covid-19} vaccine in a nationwide mass vaccination setting},
  author={Dagan, Noa and Barda, Noam and Kepten, Eldad and Miron, Oren and Perchik, Shay and Katz, Mark A and Hern{\'a}n, Miguel A and Lipsitch, Marc and Reis, Ben and Balicer, Ran D},
  journal={New England Journal of Medicine},
  year={2021},
  publisher={Mass Medical Soc}
}

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}


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  number={476},
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  year={2006},
  publisher={Taylor \& Francis}
}

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  title={Diagnostic testing and evaluation of maximum likelihood models},
  author={Tauchen, George},
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}

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}

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  title={Modern epidemiology},
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  volume={3},
  year={2008},
  publisher={Wolters Kluwer Health/Lippincott Williams \& Wilkins Philadelphia}
}

@article{li1998simple,
  title={A simple consistent bootstrap test for a parametric regression function},
  author={Li, Qi and Wang, Suojin},
  journal={Journal of Econometrics},
  volume={87},
  number={1},
  pages={145--165},
  year={1998},
  publisher={Elsevier}
}

@article{zheng1996consistent,
  title={A consistent test of functional form via nonparametric estimation techniques},
  author={Zheng, John Xu},
  journal={Journal of Econometrics},
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  number={2},
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  year={1996},
  publisher={Elsevier}
}

@article{delgado2006consistent,
  title={Consistent tests of conditional moment restrictions},
  author={Delgado, Miguel A and Dom{\'\i}nguez, Manuel A and Lavergne, Pascal},
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  pages={33--67},
  year={2006},
  publisher={JSTOR}
}

@article{kallus2019interval,
  title={Interval estimation of individual-level causal effects under unobserved confounding},
  author={Kallus, Nathan and Mao, Xiaojie and Zhou, Angela},
  journal={International Conference on Artificial Intelligence and Statistics},
  year={2019},
}
@book{pearl2009causality,
  title={Causality},
  author={Pearl, Judea},
  year={2009},
  publisher={Cambridge university press}
}

@article{tripathi2003testing,
  title={Testing conditional moment restrictions},
  author={Tripathi, Gautam and Kitamura, Yuichi},
  journal={The Annals of Statistics},
  volume={31},
  number={6},
  pages={2059--2095},
  year={2003},
  publisher={Institute of Mathematical Statistics}
}


@article{stuart2010matching,
  title={Matching methods for causal inference: A review and a look forward},
  author={Stuart, Elizabeth A},
  journal={Statistical science: a review journal of the Institute of Mathematical Statistics},
  volume={25},
  number={1},
  pages={1},
  year={2010},
  publisher={NIH Public Access}
}

@article{jesson2021quantifying,
  title={Quantifying ignorance in individual-level causal-effect estimates under hidden confounding},
  author={Jesson, Andrew and Mindermann, S{\"o}ren and Gal, Yarin and Shalit, Uri},
  journal={International Conference on Machine Learning},
  year={2021},
}

@article{oprescu2023b,
  title={B-learner: Quasi-oracle bounds on heterogeneous causal effects under hidden confounding},
  author={Oprescu, Miruna and Dorn, Jacob and Ghoummaid, Marah and Jesson, Andrew and Kallus, Nathan and Shalit, Uri},
 journal={International Conference on Machine Learning},
  year={2023},
}


@article{dorn2021doubly,
  title={Doubly-valid/doubly-sharp sensitivity analysis for causal inference with unmeasured confounding},
  author={Dorn, Jacob and Guo, Kevin and Kallus, Nathan},
  journal={arXiv preprint arXiv:2112.11449},
  year={2021}
}

@article{dorn2022sharp,
  title={Sharp sensitivity analysis for inverse propensity weighting via quantile balancing},
  author={Dorn, Jacob and Guo, Kevin},
  journal={Journal of the American Statistical Association},
  pages={1--13},
  year={2022},
  publisher={Taylor \& Francis}
}

@article{degtiar2021conditional,
author = {Degtiar, Irina and Layton, Tim and Wallace, Jacob and Rose, Sherri},
title = {Conditional cross-design synthesis estimators for generalizability in {M}edicaid},
journal = {Biometrics},
volume = {00},
pages = {1 -- 14},
keywords = {causal inference, external validity, selection bias, transportability, unmeasured confounding},
year={2023}
}

@article{anderson2003implementation,
  title={Implementation of the {W}omen's {H}ealth {I}nitiative study design},
  author={Anderson, Garnet and Manson, Joann and Wallace, Robert and Lund, Bernedine and Hall, Dallas and Davis, Scott and Shumaker, Sally and Wang, Ching-Yun and Stein, Evan and Prentice, Ross},
  journal={Annals of Epidemiology},
  volume={13},
  number={9},
  pages={S5--S17},
  year={2003},
  publisher={Elsevier}
}

@article{hsu2013calibrating,
  title={Calibrating sensitivity analyses to observed covariates in observational studies},
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  number={4},
  pages={803--811},
  year={2013},
  publisher={Wiley Online Library}
}


@article{kennedy2023towards,
  title={Towards optimal doubly robust estimation of heterogeneous causal effects},
  author={Kennedy, Edward},
  journal={Electronic Journal of Statistics},
  volume={17},
  number={2},
  pages={3008--3049},
  year={2023},
  publisher={The Institute of Mathematical Statistics and the Bernoulli Society}
}

@article{taylor2017effects,
  title={Effects of oral vs transdermal estrogen therapy on sexual function in early postmenopause: ancillary study of the \text{Kronos Early Estrogen Prevention Study (KEEPS})},
  author={Taylor, Hugh and Tal, Aya and Pal, Lubna and Li, Fangyong and Black, Dennis and Brinton, Eliot and Budoff, Matthew and Cedars, Marcelle and Du, Wei and Hodis, Howard and others},
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  volume={177},
  number={10},
  pages={1471--1479},
  year={2017},
  publisher={American Medical Association}
}

@article{kennedy2016semiparametric,
  title={Semiparametric theory and empirical processes in causal inference},
  author={Kennedy, Edward},
  journal={Statistical causal inferences and their applications in public health research},
  pages={141--167},
  year={2016},
  publisher={Springer}
}

@article{hodis2016vascular,
  title={Vascular effects of early versus late postmenopausal treatment with estradiol},
  author={Hodis, Howard and Mack, Wendy and Henderson, Victor and Shoupe, Donna and Budoff, Matthew and Hwang-Levine, Juliana and Li, Yanjie and Feng, Mei and Dustin, Laurie and Kono, Naoko and others},
  journal={New England Journal of Medicine},
  volume={374},
  number={13},
  pages={1221--1231},
  year={2016},
  publisher={Mass Medical Soc}
}

@article{platt2018fda,
  title={The {FDA Sentinel Initiative}—an evolving national resource},
  author={Platt, Richard and Brown, Jeffrey and Robb, Melissa and McClellan, Mark and Ball, Robert and Nguyen, Michael and Sherman, Rachel},
  journal={New England Journal of Medicine},
  volume={379},
  number={22},
  pages={2091--2093},
  year={2018}
}

@article{jarow2017multidimensional,
  title={Multidimensional evidence generation and {FDA} regulatory decision making: defining and using “real-world” data},
  author={Jarow, Jonathan P and LaVange, Lisa and Woodcock, Janet},
  journal={Jama},
  volume={318},
  number={8},
  pages={703--704},
  year={2017},
  publisher={American Medical Association}
}

@article{dreyer2018advancing,
  title={Advancing a framework for regulatory use of real-world evidence: when real is reliable},
  author={Dreyer, Nancy A},
  journal={Therapeutic Innovation and Regulatory Science},
  volume={52},
  number={3},
  pages={362--368},
  year={2018},
  publisher={SAGE Publications Sage CA: Los Angeles, CA}
}

@article{chen2021minimax,
  title={Minimax rates and adaptivity in combining experimental and observational data},
  author={Chen, Shuxiao and Zhang, Bo and Ye, Ting},
  journal={arXiv preprint arXiv:2109.10522},
  year={2021}
}

@article{oberst2022understangin,
 title={Understanding the Risks and Rewards of Combining Unbiased and Possibly Biased Estimators, with Applications to Causal Inference}, 
 author={Oberst, Michael and D’Amour, Alexander and Chen, Minmin and Wang, Yuyan and Sontag, David and Yadlowsky, Steve}, 
 year={2022}, 
 month={May}, 
journal={arXiv preprint	arXiv:2205.10467}
 }

@article{keith2023rct,
  title={{RCT} Rejection Sampling for Causal Estimation Evaluation},
  author={Keith, Katherine A and Feldman, Sergey and Jurgens, David and Bragg, Jonathan and Bhattacharya, Rohit},
  journal={arXiv preprint arXiv:2307.15176},
  year={2023}
}

@article{gerber2008social,
  title={Social pressure and voter turnout: evidence from a large-scale field experiment},
  author={Gerber, Alan S and Green, Donald P and Larimer, Christopher W},
  journal={American political Science review},
  volume={102},
  number={1},
  pages={33--48},
  year={2008},
  publisher={Cambridge University Press}
}

@misc{hillstrom2008,
  author = {Hillstrom, Kevin},
  year = {2008},
  title = {The {MineThatData} e-mail analytics and data mining challenge},
  publisher = {MineThatData blog}
}

@article{olschewski1985comprehensive,
  title={Comprehensive cohort study: an alternative to randomized consent design in a breast preservation trial},
  author={Olschewski, Manfred and Scheurlen, H},
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  number={03},
  pages={131--134},
  year={1985},
  publisher={Schattauer GmbH}
}

@article{olschewski1992analysis,
  title={Analysis of randomized and nonrandomized patients in clinical trials using the comprehensive cohort follow-up study design},
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}
@article{gao2023pretest,
  title={Pretest estimation in combining probability and non-probability samples},
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  volume={17},
  number={1},
  pages={1492--1546},
  year={2023},
  publisher={The Institute of Mathematical Statistics and the Bernoulli Society}
}
@article{choudhry2017randomized,
  title={Randomized, controlled trials in health insurance systems},
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  pages={957--964},
  year={2017},
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}

@article{yuwen2023enhancing,
  title = 	 {Enhancing Treatment Effect Estimation: A Model Robust Approach Integrating Randomized Experiments and External Controls using the Double Penalty Integration Estimator},
  author =       {Cheng, Yuwen and Wu, Lili and Yang, Shu},
  journal = 	 {Conference on Uncertainty in Artificial Intelligence},
  year = 	 {2023},
}

@article{word1990state,
  title={The State of {T}ennessee’s student/teacher achievement ratio ({STAR}) Project},
  author={Word, Elizabeth and Johnston, John and Bain, Helen P and Fulton, B DeWayne and Zaharias, Jayne B and Achilles, Charles M and Lintz, Martha N and Folger, John and Breda, Carolyn},
  journal={Tennessee Board of Education},
  year={1990}
}


@inproceedings{gentzel2021and,
  title={How and why to use experimental data to evaluate methods for observational causal inference},
  author={Gentzel, Amanda M and Pruthi, Purva and Jensen, David},
  booktitle={International Conference on Machine Learning},
  pages={3660--3671},
  year={2021},
  organization={PMLR}
}

@article{franklin2019evaluating,
  title={Evaluating the use of nonrandomized real-world data analyses for regulatory decision making},
  author={Franklin, Jessica and Glynn, Robert and Martin, David and Schneeweiss, Sebastian},
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  volume={105},
  number={4},
  pages={867--877},
  year={2019},
  publisher={Wiley Online Library}
}

@article{schurman2019framework,
  title={The framework for {FDA}’s real-world evidence program},
  author={Schurman, Beth},
  journal={Applied Clinical Trials},
  volume={28},
  number={4},
  year={2019},
  publisher={MJH Life Sciences}
}

@article{kallus2018removing,
  title={Removing hidden confounding by experimental grounding},
  author={Kallus, Nathan and Puli, Aahlad Manas and Shalit, Uri},
  journal={Advances in Neural Information Processing Systems},
  year={2018}
}

@article{stuart2011use,
  title={The use of propensity scores to assess the generalizability of results from randomized trials},
  author={Stuart, Elizabeth and Cole, Stephen and Bradshaw, Catherine and Leaf, Philip},
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  volume={174},
  number={2},
  pages={369--386},
  year={2011},
  publisher={Oxford University Press}
}


@article{hartman2015sample,
  title={From sample average treatment effect to population average treatment effect on the treated: combining experimental with observational studies to estimate population treatment effects},
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}

@article{andrews2017weighting,
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  year={2017},
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}

@article{colnet2022reweighting,
  title={Reweighting the {RCT} for generalization: finite sample analysis and variable selection},
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  journal={arXiv preprint arXiv:2208.07614},
  year={2022}
}

@article{nie2021covariate,
  title={Covariate balancing sensitivity analysis for extrapolating randomized trials across locations},
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  year={2021}
}

@mastersthesis{stutz2023,
  author  = "Stutz, Alexander",
  title   = "Can Semi-Supervised Learning Improve the Estimation of Causal Treatment Effects?",
  school  = "ETH Zurich",
  year    = "2023",
  month   = "August"
}

@misc{FDA2023,
    author = {U.S. FDA},
    title = {Accelerated Approval Program},
    year = {2023}, 
    url = {https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program},
    urldate = {2023-10-13} 
}

@article{chen2015xgboost,
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  year={2015}
}

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  title={Ignorable and informative designs in survey sampling inference},
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@article{hahn2020bayesian,
  title={Bayesian regression tree models for causal inference: Regularization, confounding, and heterogeneous effects (with discussion)},
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  volume={15},
  number={3},
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  year={2020},
  publisher={International Society for Bayesian Analysis}
}

@article{o2014generalizing,
  title={Generalizing from unrepresentative experiments: a stratified propensity score approach},
  author={O'Muircheartaigh, Colm and Hedges, Larry V},
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  number={2},
  pages={195--210},
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  publisher={Oxford University Press}
}

@article{he2020clinical,
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  journal={Clinical and Translational Science},
  volume={13},
  number={4},
  pages={675--684},
  year={2020},
  publisher={Wiley Online Library}
}


@article{martinez2023efficient,
  title={An Efficient Doubly-Robust Test for the Kernel Treatment Effect},
  author={Martinez-Taboada, Diego and Ramdas, Aaditya and Kennedy, Edward},
  journal={arXiv preprint arXiv:2304.13237},
  year={2023}
}

@article{kim2024dimension,
  title={Dimension-agnostic inference using cross {U}-statistics},
  author={Kim, Ilmun and Ramdas, Aaditya},
  journal={Bernoulli},
  volume={30},
  number={1},
  pages={683--711},
  year={2024},
  publisher={Bernoulli Society for Mathematical Statistics and Probability}
}

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}