Defining estimands for efficacy assessment in single arm phase 1b or phase 2 clinical trials in oncology early development von Englert, Stefan, Mercier, François, Pilling, Elizabeth A., Homer, Victoria, Habermehl, Christina, Zimmermann, Stefan, Kan‐Dobrosky, Natalia

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Estimands for overall survival in clinical trials with treatment switching in oncology von Manitz, Juliane, Kan‐Dobrosky, Natalia, Buchner, Hannes, Casadebaig, Marie‐Laure, Degtyarev, Evgeny, Dey, Jyotirmoy, Haddad, Vincent, Jie, Fei, Martin, Emily, Mo, Mindy, Rufibach, Kaspar, Shentu, Yue, Stalbovskaya, Viktoriya, Tang, Rui, Yung, Godwin, Zhou, Jiangxiu

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Factors Influencing Prostate‐Specific Antigen Response among Men Treated with Testosterone Therapy for 6 Months von Morgentaler, Abraham, Benesh, Janet A., Denes, Bela S., Kan‐Dobrosky, Natalia, Harb, Diala, Miller, Michael G.

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A Multicenter, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Klinefelter Syndrome or Anorchia von Rogol, Alan D., M.D., Ph.D, Swerdloff, Ronald S., M.D, Reiter, Edward O., M.D, Ross, Judith L., M.D, ZumBrunnen, Troy L., Pharm.D, Pratt, Gregg A., Ph.D, Brennan, John J., Ph.D, Benesh, Janet, B.S.M.T, Kan-Dobrosky, Natalia, Ph.D, Miller, Michael G., Pharm.D

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Testosterone Replacement with 1% Testosterone Gel and Priapism: No Definite Risk Relationship von Burnett, Arthur L., Kan‐Dobrosky, Natalia, Miller, Michael G.

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A 6-month observational study of energy, sexual desire, and body proportions in hypogonadal men treated with a testosterone 1% gel von Pexman-Fieth, Claire, Behre, Hermann M., Morales, Alvaro, Kan-Dobrosky, Natalia, Miller, Michael G.

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P-139 PYRAMID Registry: An Observational Study of Adalimumab in Crohnʼs Disease von DʼHaens, Geert, Reinisch, Walter, Satsangi, Jack, Loftus, Edward, Panaccione, Remo, Castillo, Majin, Kan-Dobrosky, Natalia, Eichner, Samantha, Thakkar, Roopal

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Ethical Considerations in Adaptive Design Clinical Trials von Laage, Thomas, Loewy, John W., Menon, Sandeep, Miller, Eva R., Pulkstenis, Erik, Kan-Dobrosky, Natalia, Coffey, Christopher

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