… David Semel and Lynne Pauer are employees of Pfizer and have stock or stock options
with Pfizer. Medical writing support was provided by David Cope, PhD, of Engage Scientific …

… Pauer and Huggins were employed by Pfizer and were shareholders at the time that this
study was performed. No other authors have competing interests. This work was presented in …

… More recent discussions with the FDA have placed the boundary of "clinical significance,"
for the purpose of calculating statistical power, as a change in velocity ranging from 1.2–1.5 m/…

Objectives: Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in
the United States, Japan, and 37 other countries. The purpose of this article was to provide …

… A sample size of 261 evaluable patients per treatment group would provide 80% power to
detect a mean difference of 3.0 with a standard deviation of 8.1 in the HRSA score between …

Purpose: To determine maximum tolerated dose of CI-994, a novel oral histone deacetylase
inhibitor, in combination with carboplatin and paclitaxel in patients with advanced solid …

… FM studies (treatment difference of about 0.9 and standard deviation of about 2.0 25,26,27,28
), the sample size of 185 patients per group was expected to provide > 95% power to …

Background A lack of objective outcome measures and overreliance on subjective pain reports
in early proof-of-concept studies contribute to the high attrition of potentially effective new …

Background Fibromyalgia (FM) is a common pain condition characterized by widespread
musculoskeletal pain and tenderness. Pregabalin is an approved treatment for adults in the …

Objectives: This study used a randomized withdrawal design to evaluate the efficacy of
pregabalin versus placebo for pain relief in patients with painful diabetic peripheral neuropathy …