Trial Outcomes & Findings for Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers (NCT NCT02038842)

NCT ID: NCT02038842

Last Updated: 2025-10-14

Results Overview

Count of participants without any grade 3 or 4 adverse events (clinical or biological) related to MVA-vaccine immunisation, reported from Week 0 to Week 2 in arm 1

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

92 participants

Primary outcome timeframe

Visit Week 2

Results posted on

2025-10-14

Participant Flow

Healthy volunteers will be recruited through the ARNS network of volunteers, through advertising via media and through a dedicated website, and given a telephone number to contact. From March 2014 to March 2015, 129 participants were screened in four sites in France.

Participant milestones

Participant milestones
Measure	MVA HIV-B/LIPO-5 MVA HIV-B primes 0,5 milliliter (mL) Intramuscular at Week 0 and Week 8 LIPO-5 1mL Intramuscular boosts at Week 20 and Week 28 LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots; MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;	LIPO-5/MVA HIV-B LIPO-5 primes 1mL intramuscular at Week 0 and Week 8 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28 LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots; MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;	GTU-MultiHIV B/LIPO-5 GTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and LIPO-5 1mL intramuscular boosts at Week 20 and Week 28 LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots; GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots	GTU-MultiHIV B/MVA HIV-B GTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28 MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots; GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
Overall Study STARTED	23	23	23	23
Overall Study COMPLETED	21	21	18	19
Overall Study NOT COMPLETED	2	2	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	MVA HIV-B/LIPO-5 MVA HIV-B primes 0,5 milliliter (mL) Intramuscular at Week 0 and Week 8 LIPO-5 1mL Intramuscular boosts at Week 20 and Week 28 LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots; MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;	LIPO-5/MVA HIV-B LIPO-5 primes 1mL intramuscular at Week 0 and Week 8 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28 LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots; MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;	GTU-MultiHIV B/LIPO-5 GTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and LIPO-5 1mL intramuscular boosts at Week 20 and Week 28 LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots; GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots	GTU-MultiHIV B/MVA HIV-B GTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28 MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots; GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
Overall Study Withdrawal by Subject	2	2	0	0
Overall Study Participant decision	0	0	2	1
Overall Study Adverse Event	0	0	3	1
Overall Study Other (professional impossibility, etc.)	0	0	0	2

Baseline Characteristics

Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MVA HIV-B/LIPO-5 n=23 Participants MVA HIV-B primes 0,5mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28	LIPO-5/MVA HIV-B n=23 Participants LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/LIPO-5 n=23 Participants GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/MVA HIV-B n=23 Participants GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28	Total n=92 Participants Total of all reporting groups
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	14 Participants n=4 Participants	42 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	9 Participants n=4 Participants	50 Participants n=21 Participants
Region of Enrollment France	23 participants n=5 Participants	23 participants n=7 Participants	23 participants n=5 Participants	23 participants n=4 Participants	92 participants n=21 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	23 Participants n=7 Participants	23 Participants n=5 Participants	23 Participants n=4 Participants	92 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	26 years n=5 Participants	24 years n=7 Participants	29 years n=5 Participants	26 years n=4 Participants	27 years n=21 Participants

PRIMARY outcome

Timeframe: Visit Week 2

Count of participants without any grade 3 or 4 adverse events (clinical or biological) related to MVA-vaccine immunisation, reported from Week 0 to Week 2 in arm 1

Outcome measures

Outcome measures
Measure	MVA HIV-B/LIPO-5 n=23 Participants MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28	LIPO-5/MVA HIV-B LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/LIPO-5 GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/MVA HIV-B GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
Evaluation of the Safety of MVA HIV-B at Week 2 in Arm 1	22 Participants	—	—	—

PRIMARY outcome

Timeframe: Visit Week 30

Count of participants with a HIV-specific Interferon-gamma Enzyme Linked Immunosorbent SPOT (IFN-γ ELISPOT) response in each of the 4 arms, defined by a positive response to at least one of the stimulating HIV peptide pools (15-mer pools covering Env, Gag, Pol, and Nef) measured in stimulated Peripheral Blood Mononuclear Cell (PBMC) by a standard IFN-γ ELISPOT assay at Week 30, i.e. 2 weeks after the last vaccine immunisation.

Outcome measures

Outcome measures
Measure	MVA HIV-B/LIPO-5 n=21 Participants MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28	LIPO-5/MVA HIV-B n=21 Participants LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/LIPO-5 n=19 Participants GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/MVA HIV-B n=21 Participants GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
To Discard Vaccine Strategies With an Insufficient Level of Immunogenicity, Defined by HIV-specific IFN-γ-ELISPOT Responses, Among 4 HIV Prophylactic Prime-boost Combinations in Healthy Volunteers at Low Risk of HIV Infection	7 Participants	9 Participants	0 Participants	14 Participants

SECONDARY outcome

Timeframe: Between week 0 and week 52

Count of participants with at least one clinical/biological AE/SAE related to vaccine immunisation.

Outcome measures

Outcome measures
Measure	MVA HIV-B/LIPO-5 n=23 Participants MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28	LIPO-5/MVA HIV-B n=23 Participants LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/LIPO-5 n=23 Participants GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/MVA HIV-B n=23 Participants GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
To Assess the Tolerance of Each Prime-boost Combination Biological SAE related to vaccine immunisation	1 Participants	0 Participants	0 Participants	1 Participants
To Assess the Tolerance of Each Prime-boost Combination Clinical AE related to vaccine immunisation	22 Participants	21 Participants	21 Participants	23 Participants
To Assess the Tolerance of Each Prime-boost Combination Clinical SAE related to vaccine immunisation	0 Participants	0 Participants	2 Participants	0 Participants
To Assess the Tolerance of Each Prime-boost Combination Biological AE related to vaccine immunisation	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At W2, W10 and W22 for reporting groups : MVA HIV-B/LIPO-5 and LIPO-5/MVA HIV-B. And at W2, W6, W14 and W22 for reporting groups : GTU-MultiHIV B/LIPO-T and GTU-MultiHIV B/MVA HIV-B.

Population: The number of participants differs due to the unavailability of some participants for some of the visits planned.

In all participants having received at least 1 dose of vaccine, the count of participants with HIV-specific ELISPOT response to at least one of stimulating HIV peptide pools.

Outcome measures

Outcome measures
Measure	MVA HIV-B/LIPO-5 n=23 Participants MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28	LIPO-5/MVA HIV-B n=23 Participants LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/LIPO-5 n=23 Participants GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/MVA HIV-B n=23 Participants GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response Week 2	5 Participants	1 Participants	1 Participants	1 Participants
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response Week 6	—	—	0 Participants	1 Participants
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response Week 10	13 Participants	1 Participants	—	—
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response Week 14	—	—	0 Participants	0 Participants
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response Week 22	9 Participants	8 Participants	1 Participants	12 Participants

Adverse Events

MVA HIV-B/LIPO-5

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

LIPO-5/MVA HIV-B

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

GTU-MultiHIV B/LIPO-5

Serious events: 7 serious events

Other events: 22 other events

Deaths: 0 deaths

GTU-MultiHIV B/MVA HIV-B

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pr. Jean-Daniel Lelièvre

Service d'immunologie clinique - Hôpital Henri Mondor

Phone: +33 1 49 81 24 55

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results until their public communication.
Publication restrictions are in place

Restriction type: OTHER

Measure	MVA HIV-B/LIPO-5 n=23 participants at risk MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28	LIPO-5/MVA HIV-B n=23 participants at risk LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/LIPO-5 n=23 participants at risk GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28	GTU-MultiHIV B/MVA HIV-B n=23 participants at risk GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
Blood and lymphatic system disorders Anaemia	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Congenital, familial and genetic disorders Gilbert's syndrome	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
General disorders Asthenia	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Immune system disorders Vitiligo	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Infections and infestations Epididymitis	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Investigations Blood creatine phosphokinase increased	8.7% 2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Investigations Blood urine present	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	8.7% 2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Investigations Haemoglobin decreased	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Investigations Lipase increased	4.3% 1/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Investigations Protein urine present	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Investigations Urine protein, quantitative	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Nervous system disorders Migraine	4.3% 1/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Nervous system disorders Myelitis	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Nervous system disorders Paraesthesia	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Psychiatric disorders Bipolar disorder	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Psychiatric disorders Depression	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Psychiatric disorders Eating disorder	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
Renal and urinary disorders Proteinuria	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	4.3% 1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.	0.00% 0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.