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The final protocol, amendments, and informed consent documentation were reviewed and approved by the study center's Institutional Review Board.
The final protocol, amendments, and informed consent documentation were reviewed and approved by the study center institutional review board.
The final protocol, amendments and consent documentation were reviewed and approved by the Institutional Review Board and/or Independent Ethics Committee at each participating centre (Additional file 1).
The final protocol, amendments and informed consent documentation were reviewed and approved by the institutional review board and the independent ethics committee of each investigational centre.
The protocol and other relevant study documentation were reviewed and approved by the Ethics Committee of the National Institute of Infectious Diseases (Tokyo, Japan).
The final protocol, amendments, and informed consent documentation were reviewed and approved by the institutional review boards and the independent ethics committees at each of the investigational centers participating in the study.
Similar(51)
The documentation was reviewed and content-analysed and the projects categorised.
Study documentation was reviewed and approved by the Ethics Committee of the North Rhine Medical Council (Düsseldorf, Germany).
Project documentation was reviewed, and key staff interviewed to reconstruct the history of the program.
All study protocols, informed consent forms and trial documentation was reviewed and approved by the institutional review boards/local ethics committees of participating centers.
After completion of each dose group, treatment and adverse event documentation were reviews and the safety evaluated by an independent data safety monitoring board (DSMB) before proceeding to the next dose of DAA.
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