Visit | 1 | 2 | 3 | 4 |
---|---|---|---|---|
Week | Day -1 | 0 | 13 | 26 |
Enrolment: | ||||
 Informed consent | X |  |  |  |
 Inclusion/Exclusion | X | X |  |  |
 Randomisation |  | X |  |  |
Interventions: | ||||
 Treatment |  |
| ||
 Placebo |  |
| ||
 Dispensing of study medication |  | X | X |  |
 Collection of study medication |  |  | X | X |
 Metformin serum concentration (compliance check) |  |  |  | X |
Assessments: | ||||
 Medical history and demographics | X |  |  |  |
 Capture Adverse Events |  | X | X | X |
 Vital Signs (blood pressure, heart rate, weight, height | X | X | X | X |
 Physical examination (general and neurological) | X | X | X | X |
 Blood and urine analysis: amino acids, haematologyb, chemistryc, markers of oxidative stress and NO function |  | X | X | X |
 MFM scale | Xa |  | X | X |
 Muscle force of knee extension and elbow flexion using hand held dynamometry | Xa |  | X | X |
 6MWT | Xa |  | X | X |
 Timed function test: 10 m walking test, Supine up | Xa |  | X | X |
 MRI |  | X |  | X |