Blinding and Randomization
Blinding and Randomization
Due to the nature of the interventions, only the two phamacological interventions can be blinded. The clinicians performing the two physiological interventions cannot be blinded. Patients will be blinded.Â
Patients will be randomized in a 1:1 ratio to either of the 4 interventions. All patients will be randomized for all interventions.
The randomization is made in 3 steps: The packing of the DANOHCA boxes from the pharmacia, the packing from the sponsor/PI, and choosing of the sealed DANOHCA box by the randomizing doctor.