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Table 1 Patient timelines / scheme of interventions

From: Treatment with l-citrulline and metformin in Duchenne muscular dystrophy: study protocol for a single-centre, randomised, placebo-controlled trial

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

  1. aWill be used as baseline values
  2. bFull blood count: erythrocytes, reticulocytes, leucocytes, platelets, haemoglobin, haematocrit
  3. cLiver and renal function tests, electrolytes, urea, creatine kinase, HbA1c, cholesterol, high and low density lipoprotein (HDL, LDL) triglycerides