Study: NCT00432913

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Clinical chemistry
Description: Full blood count at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Clinical chemistry
Description: Full blood count at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Haematology
Description: Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Haematology
Description: Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Haematology
Description: Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Physical examination
Description: Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Physical examination
Description: Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Physical examination
Description: Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Vital signs
Description: Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Vital signs
Description: Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Vital signs
Description: Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Urine pregnancy test
Description: For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Urine pregnancy test
Description: For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Urine pregnancy test
Description: For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Completion of patient diary card
Description: Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Completion of patient diary card
Description: Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Completion of patient diary card
Description: Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.