To keep the record straight: Valkee has been tested clinically for both treatment efficacy and user safety according to the requirements of the EU Medical Device Directive (93/42/EEC) and is consequently an approved European medical device in Class 2a for treating Seasonal Affective Disorder (SAD, Winter blues) and its many symptoms, and is CE-marked for that.
Caelyx has consequently been approved for Kaposi's sarcoma, and is currently also marketed for metastatic breast cancer, advanced ovarian cancer and multiple myeloma.
Oxaliplatin/5-FU/FA has been shown to prolong disease-free survival in patients undergoing curative resection for stage II and III CRC compared with 5-FU/FA 5-FU/FAalone et Andre004), and has consetuently been alproved for the adjuvant therapy of patients with stage III CRC.
The list was edited by one author (mirroring the content of the curriculum suggestions) and consequently commented on and approved by a team of GPs, palliative care physicians and medical educators by email.
Finding new uses for approved drugs has consequently become a major alternative strategy for the pharma industry.
In clinical trials, pharmacological inhibitors of PDE4 developed as potential therapies for treatment of inflammatory diseases were less efficacious than preclinical data suggested [18], [21], [22]; consequently, none has yet been approved for clinical use [23], [24].
The approved protocol was consequently checked for local feasibility and expertise at Tergooi Hospital and Gelre Hospitals and permission for study implementation was obtained by the respective boards of directors.
This study is based on data obtained from an administrative medical database; consequently, it was not necessary to be approved by an ethics committee.
The Institutional review board approved the study which was consequently registered in the primary WHO register (ACTRN12612001014842), and all patients gave and signed the informed consent.
