Trial phase Screening
(pre-trial)
Randomisation and RUSH day Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 4 weeks)
Week 78+ DBPCFC
(minimum of 6 months maintenance)
Post treatment 1 clinic visit
(2 – 6 weeks after T1 DBPCFC)
Post treatment 2 clinic visit
(3 months after T1 DBPCFC)
Post treatment 3 phone interview
(6 months after T1 DBPCFC)
Post treatment 4 clinic visit
(12 months after T1 DBPCFC)
Post treatment 5 clinic visit
(3-4 years after T1 DBPCFC)
Follow up phone/email questionnaires
(every 6 months)
Final email/phone follow up
(3 years after T5)
Time point RUSH / T0 T1 T2 T3 T4 T5
Month of study (minimum) 0 0 18 > 18.5 > 21 > 24 > 30 > 54-66 > 60-96 > 90-102
Saliva X X
(week 17)
X
(first maintenance visit, plus week 49)
X X X X X
Posterior palatal swab X
Venous blood X X
(week 17)
X
(first maintenance visit, plus week 49)
X X X X X
(optional)
Faeces X X
(week 25)
X X X 1 X
Trial phase Sc
Screening
(pre-trial)
T0
RUSH day
Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 4 weeks)
T2
(final day of study treatment)
T3
(8 weeks after end of study treatment)
T4
(1 year after end of study treatment)
T5
(3 years after end of study treatment)
Month of study 0 0 18 20 30 54
Venous blood X X X X X
Faeces X X X X X

Featured measurements

frozen and brought in at post treatment 4 clinic visit

Legend

A = Administration report abstraction
C = Index child report (reporting on others)
L = Linkage (to other databases)
M = Medical records data abstraction
O = Observation/direct assessment
N = Nurse report
P = Parent/primary caregiver report
Pe = Peer report
S = Self report
T = Teacher report
X = Undefined
X BF = Pertaining to biological father
X BM = Pertaining to biological mother
C = Pertaining to index child
X F = Pertaining to father
X Fam = Pertaining to family
X G = Pertaining to grandparent(s)
X M = Pertaining to mother
X P = Pertaining to parent(s)
X Pa = Pertaining to partner
X Pe = Pertaining to peers
X Pr = Pertaining to primary caregiver
X Si = Pertaining to sibling(s)