Trial Outcomes & Findings for The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (NCT NCT02585258)

NCT ID: NCT02585258

Last Updated: 2023-07-18

Results Overview

mean of the DAS28 (disease activity score-28 joints) post baseline. Range 0-8, higher scores mean more disease activity. See link in reference list.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 451 participants
• Primary outcome timeframe: 0,3,6,12,18,24 months
• Results posted on: 2023-07-18

Participant Flow

Participant milestones

Measure	Prednisolone prednisolone 5 mg per day Prednisolone: capsules 5 mg / day	Placebo placebo capsules once per day Placebo: capsules 1 / day
Overall Study STARTED	226	225
Overall Study Started Study Meds: Safety Population	224	225
Overall Study Returned for Follow up: Modified Intention-to-treat (ITT) Population	221	223
Overall Study COMPLETED	141	137
Overall Study NOT COMPLETED	85	88

Reasons for withdrawal

Measure	Prednisolone prednisolone 5 mg per day Prednisolone: capsules 5 mg / day	Placebo placebo capsules once per day Placebo: capsules 1 / day
Overall Study Adverse Event	28	29
Overall Study Death	3	2
Overall Study Lack of Efficacy	7	9
Overall Study includes covid-related access problems	42	46
Overall Study Lost to Follow-up	5	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prednisolone n=224 Participants prednisolone 5 mg per day Prednisolone: capsules 5 mg / day	Placebo n=225 Participants placebo capsules once per day Placebo: capsules 1 / day	Total n=449 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=224 Participants	0 Participants n=225 Participants	0 Participants n=449 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=224 Participants	0 Participants n=225 Participants	0 Participants n=449 Participants
Age, Categorical >=65 years	224 Participants n=224 Participants	225 Participants n=225 Participants	449 Participants n=449 Participants
Age, Continuous	72.5 years STANDARD_DEVIATION 5.3 • n=224 Participants	72.6 years STANDARD_DEVIATION 5.4 • n=225 Participants	72.6 years STANDARD_DEVIATION 5.3 • n=449 Participants
Sex: Female, Male Female	160 Participants n=224 Participants	156 Participants n=225 Participants	316 Participants n=449 Participants
Sex: Female, Male Male	64 Participants n=224 Participants	69 Participants n=225 Participants	133 Participants n=449 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	138 participants n=224 Participants	145 participants n=225 Participants	283 participants n=449 Participants
Region of Enrollment Romania	27 participants n=224 Participants	29 participants n=225 Participants	56 participants n=449 Participants
Region of Enrollment Italy	32 participants n=224 Participants	28 participants n=225 Participants	60 participants n=449 Participants
Region of Enrollment Europe	27 participants n=224 Participants	23 participants n=225 Participants	50 participants n=449 Participants
BMI	27.2 kg/m^2 STANDARD_DEVIATION 4.5 • n=224 Participants	27.2 kg/m^2 STANDARD_DEVIATION 4.4 • n=225 Participants	27.2 kg/m^2 STANDARD_DEVIATION 4.4 • n=449 Participants
disease duration	10.8 years STANDARD_DEVIATION 10.4 • n=224 Participants	10.2 years STANDARD_DEVIATION 10.2 • n=225 Participants	10.6 years STANDARD_DEVIATION 10.3 • n=449 Participants
DAS28 (Disease activity scale-28 joints)	4.43 units on a scale STANDARD_DEVIATION 1.04 • n=224 Participants	4.60 units on a scale STANDARD_DEVIATION 1.05 • n=225 Participants	4.51 units on a scale STANDARD_DEVIATION 1.05 • n=449 Participants
Sharp-van der Heijde damage score	20.0 units on a scale STANDARD_DEVIATION 34.6 • n=200 Participants • not all patients had available radiographs for scoring	17.2 units on a scale STANDARD_DEVIATION 33.4 • n=206 Participants • not all patients had available radiographs for scoring	18.6 units on a scale STANDARD_DEVIATION 34.0 • n=406 Participants • not all patients had available radiographs for scoring

PRIMARY outcome

Timeframe: 0,3,6,12,18,24 months

Population: modified Intention-to-treat includes all patients who took study medication and attended at least one follow up visit

mean of the DAS28 (disease activity score-28 joints) post baseline. Range 0-8, higher scores mean more disease activity. See link in reference list.

Outcome measures

Measure	Prednisolone n=221 Participants prednisolone 5 mg per day Prednisolone: capsules 5 mg / day	Placebo n=223 Participants placebo capsules once per day Placebo: capsules 1 / day
Signs and Symptoms: Mean DAS28 Post Baseline 3 months	3.26 score on a scale Standard Error 0.06	3.62 score on a scale Standard Error 0.07
Signs and Symptoms: Mean DAS28 Post Baseline 6 months	3.06 score on a scale Standard Error 0.07	3.42 score on a scale Standard Error 0.07
Signs and Symptoms: Mean DAS28 Post Baseline 12 months	2.89 score on a scale Standard Error 0.07	3.25 score on a scale Standard Error 0.07
Signs and Symptoms: Mean DAS28 Post Baseline 18 months	3.02 score on a scale Standard Error 0.07	3.89 score on a scale Standard Error 0.07
Signs and Symptoms: Mean DAS28 Post Baseline 24 months	2.97 score on a scale Standard Error 0.07	3.33 score on a scale Standard Error 0.07

PRIMARY outcome

Timeframe: 24 months

AESI: (a serious adverse event [SAE], or an AE on a prespecified list of clinically relevant AEs commonly associated with the disease and glucocorticoid use

Outcome measures

Measure	Prednisolone n=224 Participants prednisolone 5 mg per day Prednisolone: capsules 5 mg / day	Placebo n=225 Participants placebo capsules once per day Placebo: capsules 1 / day
The Total Number of Patients Experiencing at Least One Adverse Event (AE) of Special Interest (AESI)	134 Participants	111 Participants

SECONDARY outcome

Timeframe: 0, 24 months

2-year change in total Sharp/van der Heijde damage score of hands and forefeet radiographs. Range of damage score: 0-448.

score at 24 months minus score at baseline: positive result means increasing/worsening of damage.

Outcome measures

Measure	Prednisolone n=221 Participants prednisolone 5 mg per day Prednisolone: capsules 5 mg / day	Placebo n=223 Participants placebo capsules once per day Placebo: capsules 1 / day
Joint Damage Progression	0.3 score on a scale Standard Deviation 1.0	1.9 score on a scale Standard Deviation 6.4

Adverse Events

Prednisolone

Serious events: 55 serious events

Other events: 169 other events

Deaths: 3 deaths

Placebo

Serious events: 46 serious events

Other events: 164 other events

Deaths: 2 deaths

Serious adverse events

Measure	Prednisolone n=224 participants at risk prednisolone 5 mg per day Prednisolone: capsules 5 mg / day	Placebo n=225 participants at risk placebo capsules once per day Placebo: capsules 1 / day
Cardiac disorders myocardial infarction	1.3% 3/224 • Number of events 4 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Cardiac disorders myocardial ischemia	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Cardiac disorders atrial fibrillation/flutter	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	1.3% 3/225 • Number of events 3 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Cardiac disorders AV block	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Cardiac disorders cardiac failure	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Cardiac disorders aortic valve stenosis	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Endocrine disorders hyperthyroidism	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Eye disorders cataract	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Gastrointestinal disorders abdominal pain	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Gastrointestinal disorders constipation	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Gastrointestinal disorders diarrhea	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Gastrointestinal disorders diverticular perforation	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Gastrointestinal disorders lower gastrointestinal hemorrhage	1.3% 3/224 • Number of events 3 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Gastrointestinal disorders enteritis	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Gastrointestinal disorders small intestinal obstruction	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
General disorders chesst discomfort/pain	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
General disorders malaise	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
General disorders pyrexia	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations abcess limb	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations appendicitis	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations bursitis infective	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations covid-19 pneumonia	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations diverticulitis	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations erysipelas	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations fungal infection	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations gastroenteritis	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations infectious pleural effusion	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations parainfluenzae infection	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations gastroenteritis, parasitic	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations sepsis	0.89% 2/224 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations septic shock	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations pneumonia	3.1% 7/224 • Number of events 8 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.89% 2/225 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations pyelonephritis	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations salmonellosis	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations upper respiratory tract infection	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.89% 2/225 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations urinary tract infection	0.89% 2/224 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.89% 2/225 • Number of events 4 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations epidydimitis	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations Postoperative abscess Hematoma infection	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations peritonitis	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Injury, poisoning and procedural complications contusion	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Injury, poisoning and procedural complications spine fracture	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.89% 2/225 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Injury, poisoning and procedural complications hip fracture	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Injury, poisoning and procedural complications multiple fractures	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Injury, poisoning and procedural complications pelvic fracture	0.89% 2/224 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Injury, poisoning and procedural complications synovial rupture	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Injury, poisoning and procedural complications tendon rupture	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Investigations prostate specific antigen increased	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Investigations weight decrease	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Metabolism and nutrition disorders decreased appetite	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Metabolism and nutrition disorders dehydration	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Metabolism and nutrition disorders hyperglycemia	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Musculoskeletal and connective tissue disorders arthritis	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Musculoskeletal and connective tissue disorders intravertebral disc protrusion	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Musculoskeletal and connective tissue disorders osteoarthritis	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.89% 2/225 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) lung carcinoma	1.8% 4/224 • Number of events 4 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	1.3% 3/225 • Number of events 3 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) basal cell carinoma	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) epenymoma	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) gastrointestinal stromal tumor	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) melanoma	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) pancreas carcinoma	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) renal cell carcinoma	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) prostate cancer	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) rectal cancer	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) urothelium transitional cell carcinoma	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders carotid atherosclerosis	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders cerebrovascular accident	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.89% 2/225 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders complex regional pain syndrome	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders facial paralysis	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders headache	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders neuralgia, intercostal	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders radicular syndrome	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders syncope	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.89% 2/225 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders transient ischemic attack	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.89% 2/225 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders intracranial hemorrhage, traumatic	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders Vertebrobasilar insufficiency	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Psychiatric disorders depression	0.89% 2/224 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders dementia, neuropsychiatric symptoms	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Renal and urinary disorders urinary tract obstruction	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders asthma	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders chronic obstructive pulmonary disease	0.89% 2/224 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders dyspnea	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders hyperventilation	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders pleural effusion	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders pneumonitis	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders cough, productive	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.89% 2/224 • Number of events 2 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Skin and subcutaneous tissue disorders skin ulcer	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Surgical and medical procedures total hip replacement	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Surgical and medical procedures thyroidectomy	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Surgical and medical procedures prostatectomy, transurethral	0.00% 0/224 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.44% 1/225 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Vascular disorders circulatory collapse	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Vascular disorders hypertensive crisis	0.45% 1/224 • Number of events 1 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	0.00% 0/225 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.

Other adverse events

Measure	Prednisolone n=224 participants at risk prednisolone 5 mg per day Prednisolone: capsules 5 mg / day	Placebo n=225 participants at risk placebo capsules once per day Placebo: capsules 1 / day
General disorders all nonserious events	75.4% 169/224 • Number of events 989 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	72.9% 164/225 • Number of events 732 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations bronchitis, nasopharyngitis, respiratory tract infection	17.9% 40/224 • Number of events 53 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	16.0% 36/225 • Number of events 50 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations urinary tract infection, cystitis	12.9% 29/224 • Number of events 52 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	7.1% 16/225 • Number of events 30 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders influenza, influenza-like illness	10.7% 24/224 • Number of events 26 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	9.8% 22/225 • Number of events 25 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Infections and infestations pneumonia	5.4% 12/224 • Number of events 17 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	4.9% 11/225 • Number of events 14 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Vascular disorders hypertension	7.6% 17/224 • Number of events 17 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	6.2% 14/225 • Number of events 14 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Nervous system disorders headache	8.0% 18/224 • Number of events 19 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	3.1% 7/225 • Number of events 7 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Respiratory, thoracic and mediastinal disorders cough	5.8% 13/224 • Number of events 13 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.	4.4% 10/225 • Number of events 11 • 2 years At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.

Additional Information

Prof Maarten Boers

Amsterdam UMC, Vrije Universiteit

Phone: +3120-4444474

Email: eb@amsterdamumc.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place