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Table 2 Visit Schedule

From: Protocol for a double-blind randomised placebo-controlled trial of lithium carbonate in patients with amyotrophic Lateral Sclerosis (LiCALS) [Eudract number: 2008-006891-31]

Pre-Randomisation Week 3/Day 21 (+/- 3 days) Week 12 (+/- 7 days) Month 12 (+/- 7 days)
A detailed list of drugs and other agents that might interact with lithium will be provided to volunteers and to their general practitioners, together with a list of 24 hour emergency contact numbers. Dose monitoring (Li levels) ALS Interventions ALS Interventions
Informed consent Biochemistry ALSFRS-R ALSFRS-R
Registration/Demographics Urine Pregnancy Test Adverse Events EQ-5D EQ-5D
SVC Concomitant medications HADS HADS
ALS History   Physical Exam (inc vital signs) Physical Exam (inc vital signs)
ALS Interventions   Dose monitoring (Li levels) ECG
Medical HistoryNeurological Exam   Haematology Dose monitoring (Li levels)
Inclusion/Exclusion Criteria Physical Exam (inc vital signs)   Biochemistry Haematology
ALSFRS-R   Urine Pregnancy Test Adverse Events Biochemistry
EQ-5D   Concomitant medications TFTs
HADS   Trial Medication Log Urine Pregnancy Test Adverse Events
ECG   Drug Dispensing & Returns Concomitant medications
Dose monitoring (Li levels)    Trial Medication Log
Haematology    Drug Dispensing & Returns
Biochemistry    
Thyroid Function Tests    
Urine Pregnancy Test    
Concomitant Medications    
Adverse Events    
Drug Dispensing    
Trial Medication Log    
Week 1/Day 7 (+/- 3 days) Week 4/Day 28 (+/- 3 days) Month 6 (+/- 7 days) Month 15 (+/- 7 days)
Dose monitoring (Li levels) Dose monitoring (Li levels) ALS Interventions ALS Interventions
Biochemistry Haematology ALSFRS-R ALSFRS-R
Urine Pregnancy Test Biochemistry EQ-5D EQ-5D
Adverse Events Urine Pregnancy Test Adverse Events HADS HADS
Concomitant medications Concomitant medications Physical Exam (inc vital signs) Physical Exam (inc vital signs)
  Trial Medication Log ECG Dose monitoring (Li levels)
  Drug Dispensing & Returns Dose monitoring (Li levels) Haematology
   Haematology Biochemistry
   Biochemistry Urine Pregnancy Test Adverse Events
   TFTs Concomitant medications
   Urine Pregnancy Test Adverse Events Trial Medication Log
   Concomitant medications Drug Dispensing & Returns
   Trial Medication Log  
   Drug Dispensing & Returns  
Week 2/Day 14 (+/- 3 days) Week 8 (+/- 3 days) Month 9 (+/- 7 days) Month 18/Week 77 (+ 7 days)
Dose monitoring (Li levels) Dose monitoring (Li levels) ALS Interventions ALS Interventions
Biochemistry Haematology ALSFRS-R ALSFRS-R
Urine Pregnancy Test Adverse Events Biochemistry EQ-5D EQ-5D
Concomitant medications Urine Pregnancy Test Adverse Events HADS HADS
  Concomitant medications Physical Exam (inc vital signs) Physical Exam (inc vital signs)
  Trial Medication Log Dose monitoring (Li levels) ECG
  Drug Dispensing & Returns Haematology Dose monitoring (Li levels)
   Biochemistry Haematology
   Urine Pregnancy Test Adverse Events Biochemistry
   Concomitant medications TFT's
   Trial Medication Log Urine Pregnancy Test Adverse Events
   Drug Dispensing & Returns Concomitant medications
    Trial Medication Log
    Drug Returns
    Unscheduled Visits