The pivotal study randomly assigned 20 patients to receive the transplant and 20 to undergo sham surgery.
A pivotal study following the renal outcomes in the DCCT cohort of participants with type 1 diabetes.
Another scheme, gemcitabine plus cisplatin, was the comparator for the pivotal study of pemetrexed.
Whittaker, S. J. et al. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma.
In a pivotal study of more than five dozen patients, researchers reported, more than 80percentt of those who got the therapy went into remission.
Neuschler, E. I. et al. A pivotal study of optoacoustic imaging to diagnose benign and malignant breast masses: a new evaluation tool for radiologists.
One pivotal study option has been the observation of clinical responses during presurgical/neoadjuvant endocrine therapy (PSET/NET).
The results of the second pivotal study in the coming months will provide further information on whether recentin may provide benefit for patients with colorectal cancer and will inform any decision about possible regulatory filings.
In a pivotal study that was the basis for the approval, Prolia reduced the incidence of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis.
A pivotal study found that if an infected person was treated with drugs immediately, the risk of transmission to an uninfected partner was cut by 96 percent.
It was likely the smallest pivotal study in FDA's modern history.
