Showing the newest 100 of 2,885 published changes. The source-record archive remains available at /updates/ ; this mixed view keeps each evidence type distinct.
Study context updated Site addition: September 20, 2026
Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: October 8, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The reported median follow-up was 5.4 years. The composite result does not establish benefit for every component, and all-cause mortality did not differ significantly. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context updated Site addition: September 20, 2026
Change in six-minute walking distance and symptom-assessment total fatigue score at week 24.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 24, 2022
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits Neither primary endpoint was met. Findings in primary mitochondrial myopathy should not be substituted for evidence in Barth syndrome. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context updated Site addition: September 20, 2026
Percentage weight change and the proportion losing at least 5% of baseline weight at week 68.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: November 19, 2021
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The main report describes treatment-period outcomes in adults without diabetes. A separately appraised extension below follows selected participants after medication and structured lifestyle support stopped; it does not provide a randomized comparison of continuing versus stopping treatment. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context updated Site addition: September 20, 2026
Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke; the registry observation window extended to 240 weeks.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: August 30, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The report gives a mean follow-up of 39.8 months. That observed follow-up differs from the maximum registry observation window. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context updated Site addition: September 20, 2026
For functional constipation, change in weekly spontaneous bowel-movement frequency over 12 weeks; the registry has a separate primary endpoint for its IBS-C cohort.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: November 26, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry covers 438 participants across two conditions. This report concerns 330 randomized children with functional constipation, of whom 328 received treatment. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context updated Site addition: September 20, 2026
Percentage weight change and the proportion losing at least 5% of baseline weight at week 72.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: July 24, 2025
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The main report concerns adults without diabetes and its 72-week weight endpoints. Separately appraised publications below examine patient-reported outcomes and exploratory physical-function subgroups from the same trial. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context updated Site addition: September 20, 2026
Percentage change in body weight at week 24.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: September 13, 2023
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The often-cited 48-week weight results are secondary outcomes; the primary endpoint was measured at week 24. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Visceral adipose tissue; the retrieved primary-outcome field does not specify a time frame.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: November 27, 2013
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The publication reports a 26-week comparison using imaging of abdominal fat. That result is not a cardiovascular-outcome trial or a general-obesity result. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Time to tumor progression or death, with assessments scheduled through week 96.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: March 5, 2025
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The report describes 204 randomized participants; the registry lists 264 enrolled. Improved progression-free survival in this report did not demonstrate improved overall survival. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Recovery of gastrointestinal function, assessed daily until hospital discharge.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: April 14, 2017
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The report describes 117 enrolled and 114 in safety and modified intention-to-treat analyses. The primary efficacy difference was not statistically significant; this route and setting do not establish effects for other proposed uses. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The proportion with a relevant reduction in pituitary tumor volume on MRI at week 48.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: October 14, 2022
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The report describes 90 entrants and 89 in the primary analysis; the registry lists 108 enrolled. These are source-specific counts, not an interchangeable analyzed population. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The proportion with at least three complete spontaneous bowel movements per week and at least one more than baseline, for at least nine of twelve weeks.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 30, 2013
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry identifies protocol MCP-103-303 and 643 enrolled participants. Only Trial 303 outcomes from the two-trial paper are shown here; the paper’s total of 1,276 covers both trials. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The proportion with at least three complete spontaneous bowel movements per week and at least one more than baseline, for at least nine of twelve weeks.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 30, 2013
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry identifies protocol LIN-MD-01 and 633 enrolled participants. Only Trial 01 outcomes from the two-trial paper are shown here; combined safety reporting should not be assigned to either trial alone. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Adverse events throughout the extension; the registry identifies safety as the primary outcome.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: October 12, 2022
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The reported 38.5-month progression-free survival starts at core-trial randomization, not extension entry. Extension entrants were selected and all received active treatment, so this is not a new randomized long-term comparison. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Direct sunlight exposure without phototoxicity-related pain between 10:00 and 15:00, from baseline through day 270.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: October 12, 2021
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits This European protocol used a different daily sunlight window and follow-up period from the US trial in the same paper. The exposure-hour totals are not directly comparable across studies. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Time to the first major cardiovascular event, tested for both safety noninferiority and efficacy superiority.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: August 8, 2018
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The safety noninferiority criterion was met, but the superiority criterion for reducing cardiovascular events was not. Those are different questions. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Time to cardiovascular death, nonfatal heart attack, nonfatal stroke or hospitalization for unstable angina.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: December 20, 2016
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The trial met its noninferiority criterion but did not show superiority. Its cardiovascular composite includes unstable-angina hospitalization, unlike some other trials in this collection. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: July 17, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The reported median follow-up was 3.8 years. The study population had type 2 diabetes and high cardiovascular risk; it does not establish the same result in lower-risk populations. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in visceral adipose tissue and liver fat at six months.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: October 30, 2017
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry lists 54 enrolled; the paper describes 50 randomized and 48 treated. This small, single-center study measured fat changes rather than long-term clinical outcomes. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Weight change and the proportions losing at least 5% or more than 10% of baseline weight at week 56; the registry also includes a later diabetes-onset endpoint.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 19, 2018
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits This paper reports the 56-week comparison. The registered 160-week diabetes-onset endpoint belongs to a longer follow-up question and should not be inferred from this report. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in the number of satisfying sexual events per month during 12 weeks of randomized treatment.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: December 18, 2014
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry lists 612 enrolled while the report describes 327 in its efficacy population. The positive result pools selected treatment groups; this phase 2 endpoint should not be substituted for the endpoints of later trials. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: October 8, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The reported median follow-up was 5.4 years. The composite result does not establish benefit for every component, and all-cause mortality did not differ significantly. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Changes in pigmentation assessed with VASI and VETF measures across specified body regions over six months.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: March 22, 2013
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The report describes 55 randomized participants with skin phototypes III to VI; the registry lists 56 enrolled. This combination comparison does not isolate the effect of afamelanotide used alone. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Direct sunlight exposure without pain between 10:00 and 18:00, recorded daily for six months.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: September 19, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry reports 93 enrolled participants while the abstract reports 94. That discrepancy remains explicit. The US and European protocols used different daily sunlight windows and follow-up periods. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in HbA1c at week 26.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: September 19, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The study continued for 52 weeks, but the primary comparison was glycemic control at week 26. Kidney measurements were secondary outcomes. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
New vertebral fractures measured from the parent-study baseline through the first six extension months.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: December 11, 2020
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry primary window ends at cumulative month 25; this later report follows the treatment sequence through month 43. Both extension groups received alendronate. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
A sustained complete spontaneous bowel-movement response over 12 treatment weeks.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: December 26, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry distinguishes 1,394 randomizations from 1,346 unique patients in the intention-to-treat population, after excluding repeat enrollments. The abstract’s randomized count is not the efficacy-analysis denominator. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
A sustained complete spontaneous bowel-movement response over 12 treatment weeks.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: May 28, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry reports 1,410 randomizations and an intention-to-treat population of 1,337 after excluding repeat enrollments. The closer-reading notes explain which populations support efficacy and safety results. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The proportion of participants awakening or returning to their normal status within 30 minutes, assessed by their caregivers.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: October 15, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits This uncontrolled study uses both patient-level and event-level outcomes. The efficacy analysis excluded events requiring other treatment before a response; its response percentage is not an all-treated success rate. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Changes in the Female Sexual Function Index desire score and the Female Sexual Distress Scale item concerning distress about low desire; the registry includes the core study and extension observation periods.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: April 9, 2021
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The selected report concerns the 24-week blinded core study. It reports improvement in both primary scales; the prespecified secondary count of satisfying sexual events did not differ significantly. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Changes in the Female Sexual Function Index desire score and the Female Sexual Distress Scale item concerning distress about low desire; the registry includes the core study and extension observation periods.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 28, 2021
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The selected report concerns the 24-week blinded core study. It reports improvement in both primary scales; the prespecified secondary count of satisfying sexual events did not differ significantly. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The proportion of the pivotal cohort reaching at least 10% weight loss after approximately one year.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: September 21, 2023
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry’s total enrollment is 15; the selected paper reports the ten-person pivotal POMC cohort. The primary one-year result is not a parallel placebo comparison, and the hunger analysis selects initial responders. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in HbA1c at week 26, pooling the dulaglutide groups.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: July 1, 2022
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The placebo-controlled comparison lasted 26 weeks; participants originally receiving placebo then received dulaglutide. The later extension is not another concurrent placebo comparison. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Sustained testosterone suppression from day 29 through day 337.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 18, 2022
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The paper describes 930 treated participants, while the registry lists 1,134 enrolled across the registered study. The primary endpoint concerns testosterone suppression rather than cancer survival. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Six-minute walking distance and total fatigue score during the controlled 12-week treatment periods.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: April 16, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The controlled phase did not meet either primary endpoint. Later open-label improvements come from a smaller group without a concurrent placebo comparison. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The proportion of the pivotal cohort reaching at least 10% weight loss after approximately one year.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: May 23, 2023
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry’s total enrollment is 15; the selected paper reports the eleven-person pivotal LEPR cohort. The primary one-year result is not a parallel placebo comparison, and the hunger analysis selects initial responders. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in six-minute walking distance and symptom-assessment total fatigue score at week 24.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 24, 2022
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits Neither primary endpoint was met. Findings in primary mitochondrial myopathy should not be substituted for evidence in Barth syndrome. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The proportion meeting the prespecified glucose-recovery criterion within 30 minutes after administration, without additional intervention.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: September 23, 2019
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits This was a crossover comparison under controlled clinical conditions. Its primary efficacy analysis and safety population differ, and it did not test caregiver performance in an emergency. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in the MDS-UPDRS part III motor score at month 12.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: November 28, 2025
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The primary assessment was performed while participants were taking their Parkinson medication. The two-month washout assessment is a different time point and does not establish durable disease modification. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage change in lumbar-spine bone mineral density at month 12.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: April 7, 2023
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The primary outcome was bone density. The selected report does not establish a reduction in fractures in this population. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage weight change and the proportion losing at least 5% of baseline weight at week 68.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: November 19, 2021
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The study had two primary weight endpoints. Its results do not describe what happens after treatment is stopped. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke; the registry observation window extended to 240 weeks.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: August 30, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The report gives a mean follow-up of 39.8 months. That observed follow-up differs from the maximum registry observation window. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage change in body weight at week 26.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: July 5, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The trial included 706 randomized participants in total. The active groups were not masked from one another; the masking concerned active treatment versus placebo. The report distinguishes trial-product and treatment-policy analyses. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
For functional constipation, change in weekly spontaneous bowel-movement frequency over 12 weeks; the registry has a separate primary endpoint for its IBS-C cohort.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: November 26, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry covers 438 participants across two conditions. This report concerns 330 randomized children with functional constipation, of whom 328 received treatment. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Two primary comparisons over 12-day assessment periods: time with glucose in the target range and the Emotional Burden score from the Diabetes Distress Scale.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: October 10, 2022
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The comparison changes both the drug combination and the meal-announcement approach. The publication describes 32 enrolled and 30 completing analysis; the registry lists 36 enrolled. Glucose noninferiority does not establish reduced emotional burden. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage weight change and the proportion losing at least 5% of baseline weight at week 72.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: July 24, 2025
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The selected report concerns the 72-week weight endpoints. Later follow-up reports require their own appraisal. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The number of participants with treatment-emergent adverse events, with observation windows varying by study part.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: December 10, 2025
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The paper contains both animal experiments and human observations. Only the human study belongs to this trial card; weight change was not the registered primary safety endpoint. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Improvement in liver histology after 48 weeks, with analyses by planned and actual maintenance treatment.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: December 3, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The reported primary result was improvement in steatohepatitis without worsening fibrosis. Improvement in fibrosis itself was a separate secondary outcome. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in HbA1c at week 24.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: July 3, 2023
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The report distinguishes 281 randomized participants from 275 included in efficacy analyses. Weight change at week 36 was a secondary endpoint. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage change in body weight at week 24.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: September 13, 2023
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The often-cited 48-week weight results are secondary outcomes; the primary endpoint was measured at week 24. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in infarct volume from day 0 to days 3 and 9.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: April 11, 2023
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry lists imaging as the primary outcome; the article emphasizes feasibility and safety. Six uncontrolled observations cannot establish treatment efficacy or safety. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The number of participants with treatment-emergent adverse events through day 110.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: July 27, 2023
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry primary outcome concerns adverse events; the publication calls liver-fat change its primary efficacy outcome. This is an extension cohort, and MRI liver fat is not a biopsy-based fibrosis outcome. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The number of treatment-emergent adverse events, with follow-up windows of 22, 31 or 105 days depending on study part.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: June 15, 2025
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The 144 participants were spread across different study parts. Weight-related outcomes were exploratory, and the parts did not all share the same treatment duration. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage weight change and the proportion losing at least 5% of baseline weight at week 68.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 28, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits These are combination-treatment results. The paper identifies a treatment-policy analysis; its estimates should not be mixed with a different estimand without checking the analysis definition. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage weight change and the proportion losing at least 5% of baseline weight at week 68, comparing the combination with placebo.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: August 31, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The registry still lists estimated enrollment of 3,400; the report describes 3,417 randomized participants. Its headline combination-versus-placebo result is not a cagrilintide-alone result. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in HbA1c from baseline to week 28.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: August 23, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits This active-comparator trial concerns selected treatment groups in a specified diabetes population. It does not rank the drugs across other conditions, treatment settings or long-term outcomes. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage weight change and the proportion losing at least 5% of baseline weight at week 32.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: November 12, 2024
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The study continued to week 48, but the coprimary endpoints were assessed at week 32. Its population and analysis definition should accompany any quoted weight result. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage change in body weight at week 52.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: January 20, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The 592 randomized participants included 465 without diabetes and 127 with type 2 diabetes. These cohorts and the treatment-policy and efficacy estimates should remain separate. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Two histology outcomes at week 24: disease resolution without worsening fibrosis, and fibrosis improvement without worsening disease; the registry also lists adverse events through week 52.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: May 18, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The selected publication reports the 24-week analysis. One histology endpoint was met and the other was not; this should not be summarized as demonstrated fibrosis benefit. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
The number of treatment-emergent adverse events, assessed through the end of each study part.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: November 19, 2025
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits Weight findings came from small cohorts followed for different lengths of time. The authors reported substantial withdrawal, which limits interpretation of the estimates. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage weight change and the proportion losing at least 5% of baseline weight at week 76.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: March 12, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The paper describes 725 participants and the registry lists 726 enrolled. Its treatment-regimen estimates include treatment discontinuation and other specified intercurrent events; they should not be mixed with efficacy estimates from a different analysis. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage change in body weight at week 32.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: April 21, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The trial continued to week 48, but its primary weight endpoint was at week 32. Its hypothetical efficacy estimand and US population should remain distinct from the GLORY-1 report. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in HbA1c at week 40.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: September 9, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits This report uses an efficacy estimand and a population already receiving basal insulin. Its estimates answer a different question from the REDEFINE weight-management trials. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in HbA1c at week 40.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: April 2, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The primary outcome concerns blood glucose; weight change was secondary. These efficacy-estimand results should not be ranked directly against treatment-policy estimates from other populations. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in HbA1c from baseline to week 40.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: March 5, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The trial randomized 537 of 930 screened participants. Weight change was secondary to the primary glycemic endpoint; this 40-week study does not establish long-term cardiovascular outcomes. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Change in HbA1c from baseline to week 36.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: August 13, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits Both reports share NCT06542874: 186 participants in the oral cohort and 262 in the subcutaneous cohort. They are two route reports within one registered study, not independent trial replications. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Total drug exposure, measured as area under the concentration-time curve from time zero to infinity, using samples collected through day 28.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: March 30, 2025
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The 42 participants were divided among five renal-function groups. This short pharmacokinetic study does not establish treatment benefit, long-term safety or a dosing recommendation. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage change in body weight at week 28.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: March 23, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits The retrieved registry marks the study completed and enrollment as actual, but contains no posted results. A completed registry status alone does not supply an effect estimate. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Study context added Site addition: September 20, 2026
Percentage change in body weight at week 28.
Sources, dates and limits
Site addition September 20, 2026
Source date Registry source date: September 9, 2026
Review date September 20, 2026
Source checked September 20, 2026 Meaning and limits This registered population has type 2 diabetes. The retrieved record contains no posted results; this card does not substitute for a published results appraisal. Registry information is sponsor-submitted; a registry check does not refresh the article appraisal or establish a treatment recommendation.
Human Evidence Review updated Site addition: September 20, 2026
The selected cagrilintide-alone study reported weight reduction. Later combination trials reported weight or glycemic improvements, but their results cannot be attributed to cagrilintide alone. Gastrointestinal adverse events were common, and a correction to REIMAGINE 2 remains to be reconciled.
Sources, dates and limits
Site addition September 20, 2026
Review date September 20, 2026 Meaning and limits Do larger and longer trials confirm durability, characterize uncommon harms, and show outcomes after treatment stops?
Public sources Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial ↗ Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. ↗ Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. ↗ Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. ↗ Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study. ↗ Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study. ↗ Human Evidence Review updated Site addition: September 20, 2026
The EPP trials reported longer pain-free sunlight exposure. Evidence in vitiligo concerns combination treatment with phototherapy; the six-person stroke study cannot establish treatment benefit or safety. Results from these different settings should not be pooled.
Sources, dates and limits
Site addition September 20, 2026
Review date September 20, 2026 Meaning and limits How durable are benefits and harms in broader EPP populations, including those underrepresented in the trials?
Human Evidence Review updated Site addition: September 20, 2026
RECONNECT reported improvements in desire and related distress in premenopausal women with hypoactive sexual desire disorder. Nausea, flushing and headache were more frequent with bremelanotide. Safety analyses overlap the efficacy-trial population.
Sources, dates and limits
Site addition September 20, 2026
Review date September 20, 2026 Meaning and limits How do the magnitude of symptom changes, treatment discontinuation and patient preferences affect interpretation?
Human Evidence Review updated Site addition: September 20, 2026
Controlled studies found high recovery rates after experimentally induced hypoglycemia. A small uncontrolled study also reported recovery during spontaneous episodes. Laboratory recovery times and trained-caregiver observations do not establish equivalent performance in every emergency.
Sources, dates and limits
Site addition September 20, 2026
Review date September 20, 2026 Human Evidence Review updated Site addition: September 20, 2026
In the reviewed pelvic-pain trial, both treatment groups improved without a significant between-group difference. In the prostate-cancer trial, the oral comparator produced more sustained testosterone suppression than leuprolide; that biochemical endpoint does not establish a difference in cancer survival.
Sources, dates and limits
Site addition September 20, 2026
Review date September 20, 2026 Meaning and limits How do the compared approaches affect long-term patient-important outcomes, harms, and treatment persistence beyond the reviewed follow-up windows?
Human Evidence Review updated Site addition: September 20, 2026
Randomized trials reported improved bowel-movement measures over 12 weeks. Diarrhea is an important adverse effect; the pediatric trial included a serious dehydration event related to severe diarrhea.
Sources, dates and limits
Site addition September 20, 2026
Review date September 20, 2026 Human Evidence Review updated Site addition: September 20, 2026
The trials found more participants met prespecified bowel-response endpoints with plecanatide than placebo. Diarrhea occurred more often with active treatment; these 12-week studies do not establish comparative superiority to other medicines.
Sources, dates and limits
Site addition September 20, 2026
Review date September 20, 2026 Human Evidence Review updated Site addition: September 20, 2026
The reviewed studies reported substantial weight reductions in some participants with specific genetic diagnoses. The cohorts were very small, and the Bardet-Biedl and Alström trial reported inconclusive results for the Alström subgroup.
Sources, dates and limits
Site addition September 20, 2026
Review date September 20, 2026 Meaning and limits How durable are benefits and harms across each genetic subgroup, and which baseline features predict response in these exceptionally small populations?
Public sources Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials ↗ Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period ↗ Official-source note updated Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: May 11, 2026; Cited source date: July 23, 2026
Review date September 19, 2026
Source checked September 19, 2026 Official-source note updated Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal. Earlier dated FDA and registry findings remain separately attributed below.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: February 27, 2026; Cited source date: April 22, 2026; Cited source date: May 14, 2026
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Check later results and eligibility changes for NCT07437586; registration alone is not a clinical finding.
Official-source note updated Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal. Earlier dated FDA and registry findings remain separately attributed below.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: July 3, 2023; Cited source date: September 13, 2023; Cited source date: August 21, 2026; Cited source date: August 24, 2026; Cited source date: September 1, 2026
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Reconcile phase 2 registry estimates with primary publications and preserve time points and estimands.
Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: December 11, 2020; Cited source date: April 7, 2023
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Reconcile ATOM missing-data methods and fracture outcomes with the primary report and regulatory supplement.
Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: April 27, 2025; Cited source date: July 27, 2026
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Appraise the six-person variegate-porphyria report and reconcile outcome definitions and safety details.
Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: March 5, 2025; Cited source date: November 19, 2025
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Match oral and subcutaneous publications to exact protocols and reconcile their analysis populations.
Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: July 5, 2024; Cited source date: December 23, 2025
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Appraise later monotherapy and CagriSema reports separately, including discontinuation and safety denominators.
Official-source note published Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: December 4, 2024
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected sections of the November 16, 2022 FDA pediatric supplement review, separate from the original adult EMA assessment and later regulatory changes.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: November 16, 2022
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Reconcile the pooled point-estimate discrepancy against the statistical review and trial publication.
Official-source note published Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: July 23, 2026
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: July 23, 2026
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: October 29, 2024
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: July 23, 2026
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: December 10, 2025; Cited source date: January 20, 2026
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Appraise the phase 1 and phase 2 publications, including weight outcomes absent from these registry results.
Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: November 17, 2025; Cited source date: April 21, 2026
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Reconcile Chinese and international trial families and current jurisdiction-specific regulatory documents.
Official-source note published Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: July 23, 2026
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: November 29, 2023; Cited source date: May 18, 2026
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: March 23, 2026; Cited source date: September 9, 2026
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Match ZUPREME publications or subsequent registry results to each protocol before adding effect estimates.
Official-source note published Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: July 23, 2026
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: November 2, 2023; Cited source date: December 3, 2024
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Reconcile primary papers and analysis plans with assigned-treatment and actual-treatment registry results.
Official-source note published Site addition: September 19, 2026
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Sources, dates and limits
Site addition September 19, 2026
Source date Cited source date: July 23, 2026
Review date September 19, 2026
Source checked September 19, 2026 Official-source note published Site addition: September 19, 2026
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Sources, dates and limits
Site addition September 19, 2026
Source dates Cited source date: June 13, 2024; Cited source date: March 13, 2026
Review date September 19, 2026
Source checked September 19, 2026 Meaning and limits Reconcile the young-child publication and regulatory extension with sentinel and randomized populations.
Official-source note published Site addition: September 16, 2026
Selected sections of FDA’s May 11, 2026 evaluation prepared for the July advisory meeting; findings remain attributed to that dated assessment.
Sources, dates and limits
Site addition September 16, 2026
Source date Cited source date: May 11, 2026
Review date September 16, 2026
Source checked September 16, 2026