EFTA00625099Set 9
30p10,397w
DOSAGE AND ADMINISTRATION).
Pharmacodynamics
Effects of VIAGRA on Erectile Response: In eight double-blind, placebo-controlled crossover
studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation
resulted ... doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind,
placebo-controlled trials of up to 6 months in duration, using a variety of study designs ... period, at baseline, at follow-up visits, and at the end of double-blind, placebo-controlled,
at-home treatment. Two of the questions from the IIEF served as primary study
https://www.justice.gov/epstein/files/DataSet%209/EFTA00625099.pdf
EFTA01092032Set 9
25p12,760w
month time frame.
The Phase II trial (n=60) was randomized, multi-centered, and
placebo-controlled. The goal was to compare the safety and efficacy
of three doses of Revascor ... small trial (N=14-
patient) that was a prospective, randomized, double-blind, placebo-controlled, feasibility trial. In the trial,
all patients were treated with the standard of care and subsequently ... consistent safety profile. In addition to its other clinical programs, Athersys is conducting a
placebo-controlled trial for ischemic stroke that will involve —140 patients. The trial began in 4Q11
https://www.justice.gov/epstein/files/DataSet%209/EFTA01092032.pdf
EFTA00566738Set 9
2016-07-1622p8,298w
existence of histamine
intolerance has been underestimated, and further studies based on double-blind, placebo-controlled provocations
are needed. In patients in whom the abovementioned symptoms are triggered ... There is poor evidence of adverse reactions to these
agents based on double-blind, placebo-controlled (DBPC) provocations (19). However, a better understanding of
the pathophysiology, clinical picture, trigger factors ... Haglmuller T, Gotz M, Jarisch R. Histamine in wine. Bronchoconstriction after a
double-blind placebo-controlled red wine provocation test. Int Arch Allergy Immunol 1996;110:397-400.
Medline
https://www.justice.gov/epstein/files/DataSet%209/EFTA00566738.pdf
EFTA00484595Set 9
2018-11-112p271w
details a rich history of the
placebo and the why behind double-blind, placebo-controlled clinical trials.
Intriguingly, a central subject in the story, Ted ICaptchuk, hypothesizes that "the
placebo
https://www.justice.gov/epstein/files/DataSet%209/EFTA00484595.pdf
EFTA00854210Set 9
2015-06-164p1,260w
analysis of the AAVL Phase2a results in wet AMD:
Trial Design: Phase Ha, Randomized, Placebo-Controled, N=32, Single Blind (Outcomes Assessor),
Primary end point: Safety; Secondary end points: Best
https://www.justice.gov/epstein/files/DataSet%209/EFTA00854210.pdf