Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus (NCT NCT03467932)

Last Updated: 2022-11-08

Results Overview

Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

373 participants

Primary outcome timeframe

baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up)

Results posted on

2022-11-08

Participant Flow

Patients were recruited into two primary Cohorts, A and B. Cohort A: 1. ORMD-0801 1X daily 2. ORMD-0801 2X daily 3. ORMD-0801 3X daily 4. Matched Placebo Sub-Cohort A 20 subjects Per FDA, excipient matched placebo; randomized single-blind, TID, same schedule as for Cohort A. Not part of primary analysis. Cohort B: 1. ORMD-0801 8 mg 1X daily 2. ORMD-0801 8 mg 2X daily 3. ORMD-0801 16 mg 1X daily 4. ORMD-0801 16 mg 2X daily 5. Excipient matched placebo once daily

After screening, patients underwent a 2-week, single-blind placebo run-in period (Visits 1\[baseline\] and 2), followed by a 12-week treatment period. Cohort A: 12-wk treatment period, 2 parts. Part 1, dose escalation interval for 2 weeks (Visits 3 and 4) Part 2, stable dose "maintenance" for 10 weeks (Visits 5-9). ; Cohort B: 12-wk treatment period, 2 parts. Part 1, stable dosing for 2 weeks (Visits 3 and 4) Part 2, stable dosing for 10 weeks, Visits 5-9).

Participant milestones

Participant milestones
Measure	Cohort A: ORMD-0801 Once Daily - QHS Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Twice Daily - BID Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Three Times Daily - TID ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: Matched Placebo Oral Capsule Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Placebo oral capsule: Placebo provided QHS, BID, TID	Cohort A (Sub-Cohort A): Excipient-Matched Placebo Three Times Daily-TID Excipient matched placebo in a non-randomized single-blind fashion, TID, dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Placebo oral capsule: Placebo provided QHS, BID, TID Per FDA, this sub-Cohort A is an exploratory endpoint, and not part of the primary analysis.	Cohort B:ORMD-0801, 8 mg Once Daily - QHS: ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 8 mg Twice Daily - BID ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Once Daily - QHS: ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Twice Daily - BID ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B - Matched Placebo Oral Capsule Cohort B - Matched Placebo Oral Capsule: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Placebo oral capsule: Placebo provided QHS, BID, TID
Overall Study STARTED	69	68	69	66	20	15	17	18	15	16
Overall Study COMPLETED	62	58	58	56	19	13	15	16	11	14
Overall Study NOT COMPLETED	7	10	11	10	1	2	2	2	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A+Cohort B Combined: Matched Oral Capsule Placebo n=82 Participants Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Placebo oral capsule: Placebo provided QHS, BID, TID This combined arm does not include the sub-cohort A, Excipient-Matched Placebo which per FDA is an exploratory endpoint, not part of the primary analysis.	Cohort A: ORMD-0801 Once Daily - QD n=69 Participants Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Twice Daily - BID n=68 Participants Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Three Times Daily - TID n=69 Participants ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B:ORMD-0801, 8 mg Once Daily - QD n=15 Participants ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 8 mg Twice Daily - BID n=17 Participants ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Once Daily - QD n=18 Participants ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Twice Daily - BID n=15 Participants ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Sub-Cohort A: Excipient Matched Placebo n=20 Participants Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	Total n=373 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	46 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Age, Continuous	55.92 years STANDARD_DEVIATION 9.914 • n=5 Participants	56.72 years STANDARD_DEVIATION 10.766 • n=7 Participants	55.68 years STANDARD_DEVIATION 10.569 • n=5 Participants	55.22 years STANDARD_DEVIATION 11.663 • n=4 Participants	53.66 years STANDARD_DEVIATION 8.22 • n=21 Participants	56.87 years STANDARD_DEVIATION 9.132 • n=8 Participants	54.98 years STANDARD_DEVIATION 11.229 • n=8 Participants	54.98 years STANDARD_DEVIATION 11.785 • n=24 Participants	64.08 years STANDARD_DEVIATION 9.218 • n=42 Participants	55.73 years STANDARD_DEVIATION 10.544 • n=42 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	27 Participants n=7 Participants	23 Participants n=5 Participants	29 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	7 Participants n=8 Participants	4 Participants n=24 Participants	8 Participants n=42 Participants	143 Participants n=42 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	42 Participants n=7 Participants	45 Participants n=5 Participants	40 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=8 Participants	11 Participants n=8 Participants	11 Participants n=24 Participants	12 Participants n=42 Participants	230 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	48 Participants n=5 Participants	36 Participants n=7 Participants	37 Participants n=5 Participants	36 Participants n=4 Participants	9 Participants n=21 Participants	8 Participants n=8 Participants	9 Participants n=8 Participants	8 Participants n=24 Participants	0 Participants n=42 Participants	191 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	32 Participants n=7 Participants	29 Participants n=5 Participants	33 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	9 Participants n=8 Participants	6 Participants n=24 Participants	20 Participants n=42 Participants	174 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	59 Participants n=7 Participants	57 Participants n=5 Participants	58 Participants n=4 Participants	12 Participants n=21 Participants	11 Participants n=8 Participants	16 Participants n=8 Participants	11 Participants n=24 Participants	17 Participants n=42 Participants	310 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants
BMI	31.137 Kg/M^2 STANDARD_DEVIATION 4.7750 • n=5 Participants	31.721 Kg/M^2 STANDARD_DEVIATION 4.9409 • n=7 Participants	30.447 Kg/M^2 STANDARD_DEVIATION 4.7710 • n=5 Participants	31.191 Kg/M^2 STANDARD_DEVIATION 4.0045 • n=4 Participants	31.759 Kg/M^2 STANDARD_DEVIATION 4.4393 • n=21 Participants	31.005 Kg/M^2 STANDARD_DEVIATION 5.0333 • n=8 Participants	31.881 Kg/M^2 STANDARD_DEVIATION 6.0514 • n=8 Participants	30.776 Kg/M^2 STANDARD_DEVIATION 5.4530 • n=24 Participants	31.310 Kg/M^2 STANDARD_DEVIATION 5.5976 • n=42 Participants	31.171 Kg/M^2 STANDARD_DEVIATION 4.7203 • n=42 Participants
HbA1c	9.46 percent HbA1c STANDARD_DEVIATION 1.434 • n=5 Participants	8.96 percent HbA1c STANDARD_DEVIATION 1.281 • n=7 Participants	9.36 percent HbA1c STANDARD_DEVIATION 1.656 • n=5 Participants	9.64 percent HbA1c STANDARD_DEVIATION 1.578 • n=4 Participants	9.83 percent HbA1c STANDARD_DEVIATION 1.759 • n=21 Participants	8.46 percent HbA1c STANDARD_DEVIATION 1.104 • n=8 Participants	8.96 percent HbA1c STANDARD_DEVIATION 1.420 • n=8 Participants	9.18 percent HbA1c STANDARD_DEVIATION 1.687 • n=24 Participants	8.93 percent HbA1c STANDARD_DEVIATION 0.929 • n=42 Participants	9.31 percent HbA1c STANDARD_DEVIATION 1.512 • n=42 Participants
Diabetes Medications Metformin Alone	22 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	12 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	6 Participants n=42 Participants	103 Participants n=42 Participants
Diabetes Medications Metformin, No Sulfonylureas, but At Least 1 Other Medication	13 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	48 Participants n=42 Participants
Diabetes Medications Metformin with Sulfonylureas Only	33 Participants n=5 Participants	30 Participants n=7 Participants	26 Participants n=5 Participants	33 Participants n=4 Participants	7 Participants n=21 Participants	7 Participants n=8 Participants	8 Participants n=8 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	151 Participants n=42 Participants
Diabetes Medications Metformin with Sulfonylureas and Other Medication(s)	10 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	40 Participants n=42 Participants
Diabetes Medications Not on Metformin, But On 1 Other Medication	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	20 Participants n=42 Participants
Diabetes Medications Not on Metformin, But On At Least 2 Other Medications	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	11 Participants n=42 Participants

PRIMARY outcome

Timeframe: baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up)

Population: Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.

Outcome measures

Outcome measures
Measure	Combined Cohort A +Cohort B: Matched-Placebo Oral Capsule n=53 Participants Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Placebo oral capsule: Placebo provided QHS, BID, TID Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	Cohort A: ORMD-0801 Once Daily - QHS n=59 Participants Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Twice Daily - BID n=54 Participants Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Three Times Daily - TID n=52 Participants ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B:ORMD-0801, 8 mg Once Daily - QHS: n=13 Participants ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 8 mg Twice Daily - BID n=12 Participants ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Once Daily - QHS: n=13 Participants ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Twice Daily - BID n=10 Participants ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.
Change From Baseline of HbA1C (Glycated Hemoglobin)	-0.13 percent HbA1C Interval -0.86 to 0.59	-0.60 percent HbA1C Interval -1.37 to 0.16	-0.59 percent HbA1C Interval -1.32 to 0.14	-0.51 percent HbA1C Interval -1.27 to 0.25	-0.95 percent HbA1C Interval -1.87 to -0.03	-0.95 percent HbA1C Interval -1.84 to -0.07	0.12 percent HbA1C Interval -0.8 to 1.04	-0.50 percent HbA1C Interval -1.47 to 0.48

SECONDARY outcome

Timeframe: Baseline (Run-In:Week 0, Visit 1) to Part 1, Visit 3, elapsed time: 3 weeks.

Population: Intend-to-Treat; data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.

Mean change from baseline (Run-In, Week 0 Visit 1) to Part 1, Visit 3 for HbA1C (measured in mmols/mol)

Outcome measures

Outcome measures
Measure	Combined Cohort A +Cohort B: Matched-Placebo Oral Capsule n=61 Participants Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Placebo oral capsule: Placebo provided QHS, BID, TID Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	Cohort A: ORMD-0801 Once Daily - QHS n=62 Participants Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Twice Daily - BID n=62 Participants Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Three Times Daily - TID n=58 Participants ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B:ORMD-0801, 8 mg Once Daily - QHS: n=14 Participants ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 8 mg Twice Daily - BID n=13 Participants ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Once Daily - QHS: n=14 Participants ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Twice Daily - BID n=14 Participants ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.
Mean Change From Baseline Over Time for HbA1C	-2.12 mmol/mol Interval -4.4 to 0.16	-2.56 mmol/mol Interval -4.94 to -0.19	-1.95 mmol/mol Interval -4.21 to 0.3	-2.91 mmol/mol Interval -5.25 to -0.57	-3.26 mmol/mol Interval -6.13 to -0.39	-5.51 mmol/mol Interval -8.3 to -2.73	-2.06 mmol/mol Interval -4.94 to 0.82	-1.87 mmol/mol Interval -4.72 to 0.98

SECONDARY outcome

Timeframe: Baseline (week 0, visit 1) to Week 10, part 2

Population: Intent-to-Treat; data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.

Change of Hb1Ac from Baseline to Week 10, measured in mmol/mol

Outcome measures

Outcome measures
Measure	Combined Cohort A +Cohort B: Matched-Placebo Oral Capsule n=53 Participants Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Placebo oral capsule: Placebo provided QHS, BID, TID Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	Cohort A: ORMD-0801 Once Daily - QHS n=58 Participants Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Twice Daily - BID n=54 Participants Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Three Times Daily - TID n=50 Participants ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B:ORMD-0801, 8 mg Once Daily - QHS: n=13 Participants ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 8 mg Twice Daily - BID n=12 Participants ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Once Daily - QHS: n=13 Participants ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Twice Daily - BID n=11 Participants ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.
Change Over Time in Hb1Ac	-1.27 mmol/mol Interval -8.88 to 6.35	-5.95 mmol/mol Interval -14.05 to 2.16	-4.95 mmol/mol Interval -12.62 to 2.73	-6.16 mmol/mol Interval -14.22 to 1.9	-10.34 mmol/mol Interval -20.01 to -0.68	-10.71 mmol/mol Interval -20.02 to -1.4	-0.25 mmol/mol Interval -9.94 to 9.44	-4.66 mmol/mol Interval -14.61 to 5.28

Adverse Events

Combined Cohort A + Cohort B: Matched Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort A: ORMD-0801 Once Daily - QD

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Cohort A: ORMD-0801 Twice Daily - BID

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort A: ORMD-0801 Three Times Daily - TID

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Cohort B:ORMD-0801, 8 mg Once Daily - QD

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort B: ORMD-0801 8 mg Twice Daily - BID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort B: ORMD-0801 16 mg Once Daily - QD

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort B: ORMD-0801 16 mg Twice Daily - BID

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Excipient Matched Placebo -TID

Serious events: 3 serious events

Other events: 13 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Combined Cohort A + Cohort B: Matched Placebo n=82 participants at risk Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Placebo oral capsule: Placebo provided QHS, BID, TID Per FDA, the sub-Cohort A, excipient-matched placebo TID is an exploratory arm and is not part of the primary analysis.	Cohort A: ORMD-0801 Once Daily - QD n=69 participants at risk Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Twice Daily - BID n=68 participants at risk Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Three Times Daily - TID n=69 participants at risk ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B:ORMD-0801, 8 mg Once Daily - QD n=15 participants at risk ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 8 mg Twice Daily - BID n=17 participants at risk ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Once Daily - QD n=18 participants at risk ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Twice Daily - BID n=15 participants at risk ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Excipient Matched Placebo -TID n=20 participants at risk Exploratory endpoint not part of primary analysis per FDA
Cardiac disorders Acute Myocardial Infarction	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Angina Pectoris	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Atrial Fibrillation	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	2.9% 2/69 • Number of events 2 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Coronary Artery Disease	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
General disorders Chest Pain	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	6.7% 1/15 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Sepsis	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Urosepsis	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Myocardial Infarction	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
General disorders Death	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Osteomyelitis	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Pneumonia	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.

Other adverse events

Other adverse events
Measure	Combined Cohort A + Cohort B: Matched Placebo n=82 participants at risk Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) Placebo oral capsule: Placebo provided QHS, BID, TID Per FDA, the sub-Cohort A, excipient-matched placebo TID is an exploratory arm and is not part of the primary analysis.	Cohort A: ORMD-0801 Once Daily - QD n=69 participants at risk Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Twice Daily - BID n=68 participants at risk Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort A: ORMD-0801 Three Times Daily - TID n=69 participants at risk ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B:ORMD-0801, 8 mg Once Daily - QD n=15 participants at risk ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 8 mg Twice Daily - BID n=17 participants at risk ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Once Daily - QD n=18 participants at risk ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Cohort B: ORMD-0801 16 mg Twice Daily - BID n=15 participants at risk ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.	Excipient Matched Placebo -TID n=20 participants at risk Exploratory endpoint not part of primary analysis per FDA
Musculoskeletal and connective tissue disorders Mulscle Spasms	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Body Tinea	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Blood and lymphatic system disorders Anemia	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	4.3% 3/69 • Number of events 3 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.5% 1/68 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.9% 1/17 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.6% 1/18 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Angina Pectoris	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Atrial Fibrillation	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	4.3% 3/69 • Number of events 3 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.5% 1/68 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	10.0% 2/20 • Number of events 2 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Atrioventricular Block First Degree	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Palpitations	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Abdominal discomfort	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Abdominal pain Upper	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Constipation	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	6.7% 1/15 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Diarrhoea	3.7% 3/82 • Number of events 3 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	2.9% 2/69 • Number of events 2 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	4.4% 3/68 • Number of events 3 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	11.6% 8/69 • Number of events 8 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	6.7% 1/15 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	15.0% 3/20 • Number of events 3 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Large Intestine Polyp	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Nausea	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	2.9% 2/69 • Number of events 2 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	6.7% 1/15 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	6.7% 1/15 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Pancreatic Cyst	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Immune system disorders Hypersensitivity	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	6.7% 1/15 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Immune system disorders Seasonal Allergy	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Acute Sinusitis	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Adenoviral upper respiratory infection	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Bronchitis	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.4% 1/69 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	1.5% 1/68 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Cellulitis	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Conjunctivitis	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Atypical Pneumonia	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Cystitis	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	6.7% 1/15 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.9% 1/17 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Diverticulitis	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	6.7% 1/15 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Gastroenteritis Viral	1.2% 1/82 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/20 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Gastrointestinal disorders Dispepsia	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Osteomyelitis	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Nasopharyngitis	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Infections and infestations Pneumonia	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Injury, poisoning and procedural complications Laceration	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Reproductive system and breast disorders Vulvovaginal Discomfort	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Vascular disorders Peripheral Arterial Occlusive Disease	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Intracardiac Mass	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Cardiac disorders Myocardial Infarction	0.00% 0/82 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/68 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/69 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/17 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/18 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	0.00% 0/15 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.	5.0% 1/20 • Number of events 1 • Each subject was followed for a period of 12 weeks Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.

Additional Information

Miriam Kidron, Ph.D.

Oramed Pharmaceuticals

Phone: +972-2-566-0100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60