Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials
IMPORTANCE: Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed. OBJECTIVE: To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms. DESIGN, SET...
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creator | Pinkerton, JoAnn V Simon, James A Joffe, Hadine Maki, Pauline M Nappi, Rossella E Panay, Nick Soares, Claudio N Thurston, Rebecca C Caetano, Cecilia Haberland, Claudia Haseli Mashhadi, Nazanin Krahn, Ulrike Mellinger, Uwe Parke, Susanne Seitz, Christian Zuurman, Lineke |
description | IMPORTANCE: Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed. OBJECTIVE: To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms. DESIGN, SETTING, AND PARTICIPANTS: Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023). INTERVENTION: Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 weeks followed by elinzanetant, 120 mg, for 14 weeks. MAIN OUTCOMES AND MEASURES: Primary end points included mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, measured by the electronic hot flash daily diary. Secondary end points included Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and Menopause-Specific Quality of Life questionnaire total score from baseline to week 12. RESULTS: Eligible participants (mean [SD] age, OASIS 1: 54.6 [4.9] years; OASIS 2: 54.6 [4.8] years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). A total of 309 (78.0%) and 324 (81.0%) completed OASIS 1 and 2, respectively. For the elinzanetant and placebo groups, the baseline mean (SD) VMS per 24 hours were 13.4 (6.6) vs 14.3 (13.9) (OASIS 1) and 14.7 (11.1) v 16.2 (11.2) (OASIS 2). Baseline VMS severity was 2.6 (0.2) vs 2.5 (0.2) (OASIS 1) and 2.5 (0.2) vs 2.5 (0.2) (OASIS 2). Elinzanetant significantly reduced VMS frequency vs placebo at week 4 (OASIS 1: −3.3 [95% CI, −4.5 to −2.1], P |
doi_str_mv | 10.1001/jama.2024.14618 |
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OBJECTIVE: To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms. DESIGN, SETTING, AND PARTICIPANTS: Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023). INTERVENTION: Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 weeks followed by elinzanetant, 120 mg, for 14 weeks. MAIN OUTCOMES AND MEASURES: Primary end points included mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, measured by the electronic hot flash daily diary. Secondary end points included Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and Menopause-Specific Quality of Life questionnaire total score from baseline to week 12. RESULTS: Eligible participants (mean [SD] age, OASIS 1: 54.6 [4.9] years; OASIS 2: 54.6 [4.8] years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). A total of 309 (78.0%) and 324 (81.0%) completed OASIS 1 and 2, respectively. For the elinzanetant and placebo groups, the baseline mean (SD) VMS per 24 hours were 13.4 (6.6) vs 14.3 (13.9) (OASIS 1) and 14.7 (11.1) v 16.2 (11.2) (OASIS 2). Baseline VMS severity was 2.6 (0.2) vs 2.5 (0.2) (OASIS 1) and 2.5 (0.2) vs 2.5 (0.2) (OASIS 2). Elinzanetant significantly reduced VMS frequency vs placebo at week 4 (OASIS 1: −3.3 [95% CI, −4.5 to −2.1], P < .001; OASIS 2: −3.0 [95% CI, −4.4 to −1.7], P < .001) and at week 12 (OASIS 1: −3.2 [95% CI, −4.8 to −1.6], P < .001; OASIS 2: −3.2 [95% CI, −4.6 to −1.9], P < .001). Elinzanetant also improved VMS severity vs placebo at week 4 (OASIS 1: −0.3 [95% CI, −0.4 to −0.2], P < .001; OASIS 2: −0.2 [95 CI, −0.3 to −0.1], P < .001) and week 12 (OASIS 1: −0.4 [95% CI, −0.5 to −0.3], P < .001; OASIS 2: −0.3 [95% CI, −0.4 to −0.1], P < .001). Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable. CONCLUSIONS AND RELEVANCE: Elinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159]]></description><identifier>ISSN: 0098-7484</identifier><identifier>ISSN: 1538-3598</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2024.14618</identifier><identifier>PMID: 39172446</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Clinical trials ; Effectiveness ; Menopause ; Neurokinin ; Neurokinin NK1 receptors ; Placebos ; Post-menopause ; Quality of life ; Sleep</subject><ispartof>JAMA : the journal of the American Medical Association, 2024-10, Vol.332 (16), p.1343-1354</ispartof><rights>Copyright American Medical Association Oct 22-Oct 29, 2024</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a1436-6067686021583687a3afe47acf7aa7400b28edf5470f1e310c1ad4c25b25ee9f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.2024.14618$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2024.14618$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3327,27901,27902,76458,76461</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39172446$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pinkerton, JoAnn V</creatorcontrib><creatorcontrib>Simon, James A</creatorcontrib><creatorcontrib>Joffe, Hadine</creatorcontrib><creatorcontrib>Maki, Pauline M</creatorcontrib><creatorcontrib>Nappi, Rossella E</creatorcontrib><creatorcontrib>Panay, Nick</creatorcontrib><creatorcontrib>Soares, Claudio N</creatorcontrib><creatorcontrib>Thurston, Rebecca C</creatorcontrib><creatorcontrib>Caetano, Cecilia</creatorcontrib><creatorcontrib>Haberland, Claudia</creatorcontrib><creatorcontrib>Haseli Mashhadi, Nazanin</creatorcontrib><creatorcontrib>Krahn, Ulrike</creatorcontrib><creatorcontrib>Mellinger, Uwe</creatorcontrib><creatorcontrib>Parke, Susanne</creatorcontrib><creatorcontrib>Seitz, Christian</creatorcontrib><creatorcontrib>Zuurman, Lineke</creatorcontrib><title>Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description><![CDATA[IMPORTANCE: Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed. OBJECTIVE: To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms. DESIGN, SETTING, AND PARTICIPANTS: Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023). INTERVENTION: Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 weeks followed by elinzanetant, 120 mg, for 14 weeks. MAIN OUTCOMES AND MEASURES: Primary end points included mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, measured by the electronic hot flash daily diary. Secondary end points included Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and Menopause-Specific Quality of Life questionnaire total score from baseline to week 12. RESULTS: Eligible participants (mean [SD] age, OASIS 1: 54.6 [4.9] years; OASIS 2: 54.6 [4.8] years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). A total of 309 (78.0%) and 324 (81.0%) completed OASIS 1 and 2, respectively. For the elinzanetant and placebo groups, the baseline mean (SD) VMS per 24 hours were 13.4 (6.6) vs 14.3 (13.9) (OASIS 1) and 14.7 (11.1) v 16.2 (11.2) (OASIS 2). Baseline VMS severity was 2.6 (0.2) vs 2.5 (0.2) (OASIS 1) and 2.5 (0.2) vs 2.5 (0.2) (OASIS 2). Elinzanetant significantly reduced VMS frequency vs placebo at week 4 (OASIS 1: −3.3 [95% CI, −4.5 to −2.1], P < .001; OASIS 2: −3.0 [95% CI, −4.4 to −1.7], P < .001) and at week 12 (OASIS 1: −3.2 [95% CI, −4.8 to −1.6], P < .001; OASIS 2: −3.2 [95% CI, −4.6 to −1.9], P < .001). Elinzanetant also improved VMS severity vs placebo at week 4 (OASIS 1: −0.3 [95% CI, −0.4 to −0.2], P < .001; OASIS 2: −0.2 [95 CI, −0.3 to −0.1], P < .001) and week 12 (OASIS 1: −0.4 [95% CI, −0.5 to −0.3], P < .001; OASIS 2: −0.3 [95% CI, −0.4 to −0.1], P < .001). Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable. CONCLUSIONS AND RELEVANCE: Elinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159]]></description><subject>Clinical trials</subject><subject>Effectiveness</subject><subject>Menopause</subject><subject>Neurokinin</subject><subject>Neurokinin NK1 receptors</subject><subject>Placebos</subject><subject>Post-menopause</subject><subject>Quality of life</subject><subject>Sleep</subject><issn>0098-7484</issn><issn>1538-3598</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpdkc1r3DAQxUVpaLZpz4UeiiCXXrzRt-TeliVNAwmBbtoexawtES-WtbVkaPLXR84mPWQuD2Z-80biIfSJkiUlhJ7tIMCSESaWVChq3qAFldxUXNbmLVoQUptKCyOO0fuUdqQU5fodOuY11UwItUD_zvtueIDBZRgy9nHE-c7h29FBDq50ose_IcUQcxlt7sM-x5DwKqXYdJBdi_90-Q5fuyHuYUruG75ZbS43mGIYWszwzyIxdA8FXJdDXQN9Me-gTx_QkS_iPj7rCfr1_fx2_aO6urm4XK-uKqCCq0oRpZVRhFFpuDIaOHgnNDReA2hByJYZ13opNPHUcUoaCq1omNwy6Vzt-Qn6evDdj_Hv5FK2oUuN6_vy5zgly0ktlaGs1gU9fYXu4jQO5XWWU06MkULO1NmBasaY0ui83Y9dgPHeUmLnUOwcip1DsU-hlI0vz77TNrj2P_-SQgE-H4B58WXKDGNaKf4IhXiPdw</recordid><startdate>20241022</startdate><enddate>20241022</enddate><creator>Pinkerton, JoAnn V</creator><creator>Simon, James A</creator><creator>Joffe, Hadine</creator><creator>Maki, Pauline M</creator><creator>Nappi, Rossella E</creator><creator>Panay, Nick</creator><creator>Soares, Claudio N</creator><creator>Thurston, Rebecca C</creator><creator>Caetano, Cecilia</creator><creator>Haberland, Claudia</creator><creator>Haseli Mashhadi, Nazanin</creator><creator>Krahn, Ulrike</creator><creator>Mellinger, Uwe</creator><creator>Parke, Susanne</creator><creator>Seitz, Christian</creator><creator>Zuurman, Lineke</creator><general>American Medical Association</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20241022</creationdate><title>Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials</title><author>Pinkerton, JoAnn V ; Simon, James A ; Joffe, Hadine ; Maki, Pauline M ; Nappi, Rossella E ; Panay, Nick ; Soares, Claudio N ; Thurston, Rebecca C ; Caetano, Cecilia ; Haberland, Claudia ; Haseli Mashhadi, Nazanin ; Krahn, Ulrike ; Mellinger, Uwe ; Parke, Susanne ; Seitz, Christian ; Zuurman, Lineke</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a1436-6067686021583687a3afe47acf7aa7400b28edf5470f1e310c1ad4c25b25ee9f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Clinical trials</topic><topic>Effectiveness</topic><topic>Menopause</topic><topic>Neurokinin</topic><topic>Neurokinin NK1 receptors</topic><topic>Placebos</topic><topic>Post-menopause</topic><topic>Quality of life</topic><topic>Sleep</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pinkerton, JoAnn V</creatorcontrib><creatorcontrib>Simon, James A</creatorcontrib><creatorcontrib>Joffe, Hadine</creatorcontrib><creatorcontrib>Maki, Pauline M</creatorcontrib><creatorcontrib>Nappi, Rossella E</creatorcontrib><creatorcontrib>Panay, Nick</creatorcontrib><creatorcontrib>Soares, Claudio N</creatorcontrib><creatorcontrib>Thurston, Rebecca C</creatorcontrib><creatorcontrib>Caetano, Cecilia</creatorcontrib><creatorcontrib>Haberland, Claudia</creatorcontrib><creatorcontrib>Haseli Mashhadi, Nazanin</creatorcontrib><creatorcontrib>Krahn, Ulrike</creatorcontrib><creatorcontrib>Mellinger, Uwe</creatorcontrib><creatorcontrib>Parke, Susanne</creatorcontrib><creatorcontrib>Seitz, Christian</creatorcontrib><creatorcontrib>Zuurman, Lineke</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pinkerton, JoAnn V</au><au>Simon, James A</au><au>Joffe, Hadine</au><au>Maki, Pauline M</au><au>Nappi, Rossella E</au><au>Panay, Nick</au><au>Soares, Claudio N</au><au>Thurston, Rebecca C</au><au>Caetano, Cecilia</au><au>Haberland, Claudia</au><au>Haseli Mashhadi, Nazanin</au><au>Krahn, Ulrike</au><au>Mellinger, Uwe</au><au>Parke, Susanne</au><au>Seitz, Christian</au><au>Zuurman, Lineke</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2024-10-22</date><risdate>2024</risdate><volume>332</volume><issue>16</issue><spage>1343</spage><epage>1354</epage><pages>1343-1354</pages><issn>0098-7484</issn><issn>1538-3598</issn><eissn>1538-3598</eissn><abstract><![CDATA[IMPORTANCE: Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed. OBJECTIVE: To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms. DESIGN, SETTING, AND PARTICIPANTS: Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023). INTERVENTION: Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 weeks followed by elinzanetant, 120 mg, for 14 weeks. MAIN OUTCOMES AND MEASURES: Primary end points included mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, measured by the electronic hot flash daily diary. Secondary end points included Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and Menopause-Specific Quality of Life questionnaire total score from baseline to week 12. RESULTS: Eligible participants (mean [SD] age, OASIS 1: 54.6 [4.9] years; OASIS 2: 54.6 [4.8] years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). A total of 309 (78.0%) and 324 (81.0%) completed OASIS 1 and 2, respectively. For the elinzanetant and placebo groups, the baseline mean (SD) VMS per 24 hours were 13.4 (6.6) vs 14.3 (13.9) (OASIS 1) and 14.7 (11.1) v 16.2 (11.2) (OASIS 2). Baseline VMS severity was 2.6 (0.2) vs 2.5 (0.2) (OASIS 1) and 2.5 (0.2) vs 2.5 (0.2) (OASIS 2). Elinzanetant significantly reduced VMS frequency vs placebo at week 4 (OASIS 1: −3.3 [95% CI, −4.5 to −2.1], P < .001; OASIS 2: −3.0 [95% CI, −4.4 to −1.7], P < .001) and at week 12 (OASIS 1: −3.2 [95% CI, −4.8 to −1.6], P < .001; OASIS 2: −3.2 [95% CI, −4.6 to −1.9], P < .001). Elinzanetant also improved VMS severity vs placebo at week 4 (OASIS 1: −0.3 [95% CI, −0.4 to −0.2], P < .001; OASIS 2: −0.2 [95 CI, −0.3 to −0.1], P < .001) and week 12 (OASIS 1: −0.4 [95% CI, −0.5 to −0.3], P < .001; OASIS 2: −0.3 [95% CI, −0.4 to −0.1], P < .001). Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable. CONCLUSIONS AND RELEVANCE: Elinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159]]></abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>39172446</pmid><doi>10.1001/jama.2024.14618</doi><tpages>12</tpages></addata></record> |
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subjects | Clinical trials Effectiveness Menopause Neurokinin Neurokinin NK1 receptors Placebos Post-menopause Quality of life Sleep |
title | Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-19T02%3A51%3A14IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Elinzanetant%20for%20the%20Treatment%20of%20Vasomotor%20Symptoms%20Associated%20With%20Menopause:%20OASIS%201%20and%202%20Randomized%20Clinical%20Trials&rft.jtitle=JAMA%20:%20the%20journal%20of%20the%20American%20Medical%20Association&rft.au=Pinkerton,%20JoAnn%20V&rft.date=2024-10-22&rft.volume=332&rft.issue=16&rft.spage=1343&rft.epage=1354&rft.pages=1343-1354&rft.issn=0098-7484&rft.eissn=1538-3598&rft_id=info:doi/10.1001/jama.2024.14618&rft_dat=%3Cproquest_cross%3E3095681297%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3130885457&rft_id=info:pmid/39172446&rft_ama_id=2822766&rfr_iscdi=true |