Table 1 Procedure and evaluation times of the trial

Visit number

1

2

3

4

Recruitment & Clinical assessment

Signing of informed consent

X

Diagnosis

X

Inclusion/exclusion criteria

X

Sociodemographic variables

X

Pain assessed with sphygmomanometer

X

X

X

X

Pain assessed with Analogue Visual Scale

X

X

X

X

Cognitive function (assessed with MEC)

X

X

X

X

Global function (evaluated by FIQ)

X

X

X

X

Anxiety and depression (assessed with HADS)

X

X

X

X

Quality of life (assessed by EuroQol 5D)

X

X

X

X

Clinical Global Impression (CGI)

X

X

X

X

Neuroimage assessment

Magnetic resonance spectroscopy

X

X

Safety assessments

Adverse events

X

X

X

Other study procedures

Delivery of the research drug

X

X

X

Inventory of drug taken back and used

X

X

X

Concomitant pharmacological treatment

X

X

X

X