The aim was to provide data for trial-supporting pharmacodynamic molecular assays, trial design and possibly identification of additional mechanisms of GSAO action.
*Total n=294 supplemental indications and n=201 original indications for 164 novel therapeutic agents; no study comparator information for trials supporting supplemental indication approval for celecoxib (Celebrex) in July 2005 or original indication approval for fluvastatin (Lescol, Novartis, Basel, Switzerland) in December 1993.
As for the request for free trial support, there are currently 636 apps backing this cause on the union's website – and the majority are indie developers looking to grow their businesses, not the major players.
HJL has received financial support for consultation and clinical trial support from Novartis and clinical trial support from Merck.
The protocol for this trial, supporting CONSORT checklist and a Spanish translation of the article are available as supporting information; see Protocol S1, Checklist S1 and Spanish S1.
The protocol for this trial, supporting CONSORT checklist, and CONSORT flowchart are available as supporting information; see Protocol S1, Checklist S1 and Figure S1.
EJW is responsible for the data management and trial support.
This paper presents the study protocol for the SMILES trial: "Supporting the Modification of lifestyle In Lowered Emotional States".
The existence of cost-effective manufacturing processes capable of delivering high amounts of high-quality plasmid DNA (pDNA) is essential to generate enough material for trials and support future commercialization.
In addition, there was some evidence that those responsible for clinical trials supported the return of results to those who took part (for examples of these studies see Di Blasi et al., 2002; Fernandez et al., 2003; Partridge et al., 2004).
