Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. (NCT NCT03277690)

Last Updated: 2022-11-08

Results Overview

Urinary free cortisol (UFC) level measurement: Loss of therapeutic response is inferred based on mUFC from three 24-hour UFC measurements obtained at any visit from second through final Randomized Withdrawal Phase visits (RW1 through RW5 inclusive) when: (1) mUFC is above 1.5X the ULN of the central laboratory's reference range, OR (2) mUFC is more than 40% above the baseline (RW0) value, if the RW0 value is above the ULN (i.e. \>1.0X ULN)1, OR (3) an early rescue criterion is met.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

84 participants

Primary outcome timeframe

max. 9.5 weeks

Results posted on

2022-11-08

Participant Flow

Variable therapeutic response results in customized therapeutic doses (TD). The study design included an initial Titration-maintenance phase to identify a TD for each subject. It included a requirement for maintenance at TD for at least 4 weeks prior to entering the Randomized-withdrawal (RW) phase. Then a 1:1 RW to placebo was used to establish efficacy of the active therapy. 5 additional subjects began directly in RW after completing the parent study without requiring re-titration to TD.

Participant milestones

Participant milestones
Measure	Levoketoconazole Double blind withdrawal phase: Levoketoconazole (up to a dose of 1200 mg); Double blind restoration phase: Levoketoconazole plus Placebo Levoketoconazole: During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily. During the double-blind Restoration Phase, patients will receive levoketoconazole plus placebo.	Placebo Double blind withdrawal phase: Placebo; Double blind restoration phase: Placebo plus Levoketoconazole Placebo: During the double-blind Withdrawal Phase, patients will receive placebo tablets. During the double-blind Restoration Phase, patients will receive placebo plus levoketoconazole.
Dose Titration and Maintenance STARTED	79	0
Dose Titration and Maintenance COMPLETED	39	0
Dose Titration and Maintenance NOT COMPLETED	40	0
Randomized Withdrawal STARTED	22	22
Randomized Withdrawal Subjects Which Were Previous Levoketoconazole Study Completers	1	4
Randomized Withdrawal Subjects That Are Levoketoconazole Treatment naïve Subjects	21	18
Randomized Withdrawal COMPLETED	21	22
Randomized Withdrawal NOT COMPLETED	1	0
Restoration STARTED	21	22
Restoration Subjects Which Were Previous Levoketoconazole Study Completers	1	4
Restoration Subjects That Are Levoketoconazole Treatment naïve Subjects	20	18
Restoration COMPLETED	21	22
Restoration NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Levoketoconazole Double blind withdrawal phase: Levoketoconazole (up to a dose of 1200 mg); Double blind restoration phase: Levoketoconazole plus Placebo Levoketoconazole: During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily. During the double-blind Restoration Phase, patients will receive levoketoconazole plus placebo.	Placebo Double blind withdrawal phase: Placebo; Double blind restoration phase: Placebo plus Levoketoconazole Placebo: During the double-blind Withdrawal Phase, patients will receive placebo tablets. During the double-blind Restoration Phase, patients will receive placebo plus levoketoconazole.
Dose Titration and Maintenance Protocol Violation	3	0
Dose Titration and Maintenance Physician Decision	1	0
Dose Titration and Maintenance Sponsor decision - Randomization closed	4	0
Dose Titration and Maintenance Lack of Efficacy	9	0
Dose Titration and Maintenance Adverse Event	15	0
Dose Titration and Maintenance Withdrawal by Subject	8	0
Randomized Withdrawal Withdrawal by Subject	1	0

Baseline Characteristics

A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levoketoconazole n=22 Participants Double blind withdrawal phase: Levoketoconazole (up to a dose of 1200 mg); Double blind restoration phase: Levoketoconazole plus Placebo Levoketoconazole: During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily. During the double-blind Restoration Phase, patients will receive levoketoconazole plus placebo.	Placebo n=22 Participants Double blind withdrawal phase: Placebo; Double blind restoration phase: Placebo plus Levoketoconazole Placebo: During the double-blind Withdrawal Phase, patients will receive placebo tablets. During the double-blind Restoration Phase, patients will receive placebo plus levoketoconazole.	Total n=44 Participants Total of all reporting groups
Age, Continuous	45.0 years STANDARD_DEVIATION 11.97 • n=5 Participants	43.6 years STANDARD_DEVIATION 10.96 • n=7 Participants	44.3 years STANDARD_DEVIATION 11.36 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Greece	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Romania	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Hungary	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Poland	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Italy	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Israel	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Bulgaria	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment France	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Receiving Anti-hypertensive Medication at Baseline Yes	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Receiving Anti-hypertensive Medication at Baseline No	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Receiving Anti-diabetic Medication at Baseline Yes	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Receiving Anti-diabetic Medication at Baseline No	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Anatomical etiology of endogenous Cushing's syndrome Cushing's Disease	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Anatomical etiology of endogenous Cushing's syndrome Ectopic ACTH Secretion	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Anatomical etiology of endogenous Cushing's syndrome Adrenal-Dependent	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Anatomical etiology of endogenous Cushing's syndrome Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Mean Urinary Free Cortisol (mUFC)	738.69 nmol/24 hours STANDARD_DEVIATION 1067.025 • n=5 Participants	411.59 nmol/24 hours STANDARD_DEVIATION 436.176 • n=7 Participants	575.14 nmol/24 hours STANDARD_DEVIATION 822.384 • n=5 Participants

PRIMARY outcome

Timeframe: max. 9.5 weeks

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Levoketoconazole n=22 Participants Double blind withdrawal phase: Levoketoconazole (up to a dose of 1200 mg); Double blind restoration phase: Levoketoconazole plus Placebo Levoketoconazole: During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily. During the double-blind Restoration Phase, patients will receive levoketoconazole plus placebo.	Placebo n=22 Participants Double blind withdrawal phase: Placebo; Double blind restoration phase: Placebo plus Levoketoconazole Placebo: During the double-blind Withdrawal Phase, patients will receive placebo tablets. During the double-blind Restoration Phase, patients will receive placebo plus levoketoconazole.
Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.	9 Participants	21 Participants

Adverse Events

Levoketoconazole-ITT RW Phase

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo- ITT RW Phase

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Safety Population

Serious events: 13 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Xeris Medical Director

Cortendo AB

Phone: +1 610-254-9200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Levoketoconazole-ITT RW Phase n=22 participants at risk During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily.	Placebo- ITT RW Phase n=22 participants at risk During the double-blind Withdrawal Phase, patients will receive placebo tablets.	Safety Population n=84 participants at risk The safety population for the study overall (i.e., all phases combined), referred to all subjects who received at least 1 dose of study drug during any of the 3 study phases. This includes the subjects in the TM phase as well as the additional subjects who began directly in RW who completed the parent study and did not require re-titration to a therapeutic dose.
Metabolism and nutrition disorders Hypokalemia	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	3.6% 3/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Investigations Hepatic enzyme increased	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Cardiac disorders Myocardial infarction	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
General disorders Fatigue	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	2.4% 2/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Nausea	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Umbilical hernia	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Vomiting	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Renal and urinary disorders Nephropathy toxic	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Hepatobiliary disorders Liver disorder	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	2.4% 2/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Infections and infestations Urosepsis	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	1.2% 1/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.

Other adverse events
Measure	Levoketoconazole-ITT RW Phase n=22 participants at risk During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily.	Placebo- ITT RW Phase n=22 participants at risk During the double-blind Withdrawal Phase, patients will receive placebo tablets.	Safety Population n=84 participants at risk The safety population for the study overall (i.e., all phases combined), referred to all subjects who received at least 1 dose of study drug during any of the 3 study phases. This includes the subjects in the TM phase as well as the additional subjects who began directly in RW who completed the parent study and did not require re-titration to a therapeutic dose.
Gastrointestinal disorders Nausea	9.1% 2/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	28.6% 24/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Abdominal distension	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Constipation	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	6.0% 5/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Diarrhoea	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	14.3% 12/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Dyspepsia	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Toothache	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Gastrointestinal disorders Vomiting	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	10.7% 9/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
General disorders Fatigue	9.1% 2/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	11.9% 10/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
General disorders Asthenia	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	6.0% 5/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
General disorders Oedema peripheral	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	7.1% 6/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
General disorders Pyrexia	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
General disorders Thirst	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Metabolism and nutrition disorders Decreased appetite	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	11.9% 10/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Metabolism and nutrition disorders Hypercholesterolaemia	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Metabolism and nutrition disorders Hypokalaemia	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	25.0% 21/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Metabolism and nutrition disorders Increased appetite	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Nervous system disorders Headache	9.1% 2/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	9.1% 2/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	22.6% 19/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Nervous system disorders Dizziness	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	9.1% 2/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	13.1% 11/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Nervous system disorders Paraesthesia	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Infections and infestations Cystitis	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Infections and infestations Gastroenteritis	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Infections and infestations Tonsillitis	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Infections and infestations Urinary tract infection	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Investigations Blood glucose increased	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Investigations Blood insulin increased	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Investigations Blood pressure increased	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Investigations Cortisol free urine increased	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Vascular disorders Hypertension	13.6% 3/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	23.8% 20/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Psychiatric disorders Insomnia	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	9.1% 2/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	6.0% 5/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Psychiatric disorders Anxiety	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Psychiatric disorders Depression	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Psychiatric disorders Irritability	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Cardiac disorders Palpitations	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Cardiac disorders Tachycardia paroxysmal	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Cardiac disorders Ventricular extrasystoles	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	8.3% 7/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	4.5% 1/22 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.	0.00% 0/84 • The intent to treat (ITT) population adverse events (AEs) are reported for the length of time the subject was in the randomized withdrawal (RW) phase, up to 9.5 weeks. The safety population AEs are reported for the full study length from informed consent to end of study, up to approximately 51 weeks. Untoward medical occurrence in a study subject that is temporally associated with the use of a medicinal product, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom, or disease (new or exacerbated), whether related to the study drug or study conduct or not. NOTE: Abnormal values that reflect hypercortisolism (UFCs, LNSC and serum cortisol) will not be recorded as AEs.