The study was a multinational, single-arm, open-label, 78 week trial that was recently published in the November 2, 2012 online version of the Lancet.
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Schneider CK, Melmed RD, Barstow LE, Enriquez FJ, Ranger-Moore J, Ostrem JA. Oral Human Immunoglobulin for Children with Autism and Gastrointestinal Dysfunction: A Prospective, Open-Label Study.
Obviously, an unblinded trial design (also known as an open-label trial) represents a particularly high-risk approach when the outcome involves a subjective assessment by either the patient or the physician.
Announcing the failure of the latest trial Tuesday, the two companies said they would halt development of Dimebon for all indications and cease an ongoing open-label extension study in Alzheimer's disease.
WSJ: Medivation, Pfizer Alzheimer's Drug Fails to Meet Study Goals
Amarin, which makes a new form of fish oil called Vascepa, could have marketing difficulties because doctors will draw comparisons between the niacin story and that for fish oil medicines, which showed benefit in early, open-label studies but have failed in more recent rigorous ones.
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As for Belstaff, Mr. Hilfiger will serve as a board member and adviser for the 88-year-old label, which plans to open a New York boutique this fall, followed by a five-story London flagship in 2013.
The fact that Bextra, given with an injectable drug, increased the risk of heart attacks following open-heart surgery will also be included in the Bextra label.
High-end fashion label Hugo Boss plans to open about 60 new stores in China's mainland over the next three years, just as growth in the country's luxury sector seems to be cooling off.
Unlike other cloud gaming platforms, Agawi CloudPlay is a flexible, white-label B2B solution that can be deployed on an open cloud environment, eliminating the need to build proprietary data centers.
ENGADGET: Agawi and Marvell team up to bring cloud-based gaming to Android set-top boxes
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