Processed Prediction
1. 331-201-00071 31 Confidential - Proprietary Information Amendment 4 Approval: 04 Jan 2023 20.
2. Subjects who have a history of alcohol or substance abuse (binge drinking or other substance abuse) that is currently active or that would be expected to abate within 3 months prior to the screening visit. 20.1.1 Note: The use of alcohol or other substances is strictly prohibited in the IMP. 21.
3. Subjects who have a history of abuse of controlled substances (other than alcohol) that is currently active or that would be expected to abate within 3 months prior to the screening visit. 21.1.1 Note: The use of controlled substances other than alcohol is strictly prohibited in the IMP. 22.
4. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 23.
5. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 24.
6. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 25.
7. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 26.
8. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 27.
9. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 28.
10. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 29.
11. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 30.
12. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 31.
13. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 32.
14. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 33.
15. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 34.
16. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 35.
17. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 36.
18. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 37.
19. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 38.
20. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 39.
21. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 40.
22. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 32 Protocol 331-201-00071 32 Confidential - Proprietary Information Amendment 4 Approval: 04 Jan 2023 41.
23. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 42.
24. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 43.
25. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 44.
26. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 45.
27. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 46.
28. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 47.
29. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 48.
30. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 49.
31. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 50.
32. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 51.
33. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 52.
34. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 53.
35. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 54.
36. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 55.
37. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 56.
38. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 57.
39. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 58.
40. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 59.
41. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 60.
42. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 61.
43. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 62.
44. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 63.
45. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 64.
46. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 65.
47. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 66.
48. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 67.
49. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 68.
50. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 69.
51. Subjects who have a history of abuse of alcohol or other substances that is currently active or that would be expected to abate within 3 months prior to the screening visit. 70.
52. Subjects who have a history of abuse of alcohol