Protocol and trial synopsis

a) Approved protocol

b) Approved amendments: New Appendix 7 – replacing Appendix 7 in the approved protocol.

c) Trial synopsis

Approvals and correspondence

a) The Danish Health and Medicines Authority (in Danish click here)

b) EudraCT

c) The Committees on Health Research Ethics (in Danish click here)

d) The Danish Data Protection Agency (Datatilsynet)

e) National and local approvals (site specific)