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4.2 Food Effect Cohort
TPS-SM-72/ v: 1.1/ ed:30Nov2018
C13D1
Cycle 13
predose
C15D1
Cycle 15
predose
C17D1
Cycle 17
predose
C19D1
Cycle 19
predose
C21D1
Cycle 21
predose
C23D1
Cycle 23
predose
C25D1
Cycle 25
predose
C27D1
Cycle 27
predose
C29D1
Cycle 29
predose
Within 30
EOT
days of last
dose
Unscheduled
UNS
Food Effect Cohorts
Visit
Description
FE Only
Day -18 to -4
Screening
FE Only
Day -3
Baseline
predose
FE Only
Day -3 2 hr
Baseline
post dose
C1D1
Baseline
predose
C1D1 2 hr
Baseline
post dose
C1D15
Cycle 1
predose
C3D1
Cycle 3
predose
C5D1
Cycle 5
predose
C7D1
Cycle 7
predose
C9D1
Cycle 9
predose
ECG Acquisition Guide
31
32
34
35
37
38
40
41
43
44
46
47
49
50
52
53
55
56
96
97
99
BTR Timepoint
101
102
104
105
107
108
110
111
113
114
116
117
119
120
122
123
125
126
128
129
Page 7 of 17
33
36
39
42
45
48
51
54
57
98
103
106
109
112
115
118
121
124
127
130
TM-79602-01 / v: 1.0 / ed: 27Apr2022
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