Trial Outcomes & Findings for Preventing Sexual Transmission of HIV With Anti-HIV Drugs (NCT NCT00074581)

NCT ID: NCT00074581

Last Updated: 2021-11-05

Results Overview

incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3526 participants
• Primary outcome timeframe: Throughout study
• Results posted on: 2021-11-05

Participant Flow

Participant milestones

Measure	Early-ART Participants will begin ART in addition to receiving HIV primary care Atazanavir: 300 mg taken orally once daily Didanosine: 400 mg taken orally once daily Efavirenz: 600 mg taken orally once daily Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily Lamivudine: 300 mg taken orally once daily Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily Stavudine: Dosage depends on weight Tenofovir disoproxil fumarate: 300 mg taken orally once daily Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.	Delayed-ART Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. (Same drug regimen as that described in the early-ART arm) Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
Overall Study STARTED	1789	1767
Overall Study COMPLETED	1545	1541
Overall Study NOT COMPLETED	244	226

Reasons for withdrawal

Measure	Early-ART Participants will begin ART in addition to receiving HIV primary care Atazanavir: 300 mg taken orally once daily Didanosine: 400 mg taken orally once daily Efavirenz: 600 mg taken orally once daily Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily Lamivudine: 300 mg taken orally once daily Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily Stavudine: Dosage depends on weight Tenofovir disoproxil fumarate: 300 mg taken orally once daily Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.	Delayed-ART Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. (Same drug regimen as that described in the early-ART arm) Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
Overall Study Death	15	16
Overall Study Withdrawal by Subject	50	49
Overall Study Unable to adhere to visit schedule	13	14
Overall Study Relocated	14	9
Overall Study Were withdrawn by investigator	5	2
Overall Study Lost to Follow-up	16	11
Overall Study Ended relationship w. index participant	117	106
Overall Study Other	14	19

Baseline Characteristics

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

Baseline characteristics by cohort

Measure	Early-ART n=1789 Participants Participants will begin ART in addition to receiving HIV primary care Atazanavir: 300 mg taken orally once daily Didanosine: 400 mg taken orally once daily Efavirenz: 600 mg taken orally once daily Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily Lamivudine: 300 mg taken orally once daily Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily Stavudine: Dosage depends on weight Tenofovir disoproxil fumarate: 300 mg taken orally once daily Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.	Delayed-ART n=1767 Participants Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. (Same drug regimen as that described in the early-ART arm) Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.	Total n=3556 Participants Total of all reporting groups
Age, Customized 18-25 yr	300 participants n=93 Participants	335 participants n=4 Participants	635 participants n=27 Participants
Age, Customized 26-40 yr	1101 participants n=93 Participants	1079 participants n=4 Participants	2180 participants n=27 Participants
Age, Customized >40 yr	388 participants n=93 Participants	353 participants n=4 Participants	741 participants n=27 Participants
Sex: Female, Male Female	877 Participants n=93 Participants	860 Participants n=4 Participants	1737 Participants n=27 Participants
Sex: Female, Male Male	912 Participants n=93 Participants	907 Participants n=4 Participants	1819 Participants n=27 Participants
Region North or South America	293 participants n=93 Participants	279 participants n=4 Participants	572 participants n=27 Participants
Region Asia	535 participants n=93 Participants	528 participants n=4 Participants	1063 participants n=27 Participants
Region Africa	961 participants n=93 Participants	960 participants n=4 Participants	1921 participants n=27 Participants

PRIMARY outcome

Timeframe: Throughout study

incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.

Outcome measures

Measure	Early-ART n=4325 Person Years Participants will begin ART in addition to receiving HIV primary care Atazanavir: 300 mg taken orally once daily Didanosine: 400 mg taken orally once daily Efavirenz: 600 mg taken orally once daily Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily Lamivudine: 300 mg taken orally once daily Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily Stavudine: Dosage depends on weight Tenofovir disoproxil fumarate: 300 mg taken orally once daily Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.	Delayed-ART n=4185 Person Years Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. (Same drug regimen as that described in the early-ART arm) Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms	0.07 event rate per 100 person-yr Interval 0.01 to 0.2	1.03 event rate per 100 person-yr Interval 0.74 to 1.38

PRIMARY outcome

Timeframe: Throughout study

Population: Population includes all partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases, by arm.

All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.

Outcome measures

Measure	Early-ART n=903 Participants Participants will begin ART in addition to receiving HIV primary care Atazanavir: 300 mg taken orally once daily Didanosine: 400 mg taken orally once daily Efavirenz: 600 mg taken orally once daily Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily Lamivudine: 300 mg taken orally once daily Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily Stavudine: Dosage depends on weight Tenofovir disoproxil fumarate: 300 mg taken orally once daily Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.	Delayed-ART n=890 Participants Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. (Same drug regimen as that described in the early-ART arm) Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms	0.44 event rate per 100 person-yr Interval 0.26 to 0.69	1.41 event rate per 100 person-yr Interval 1.07 to 1.82

Adverse Events

Early-ART

Serious events: 526 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed-ART

Serious events: 522 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Early-ART n=886 participants at risk Participants will begin ART in addition to receiving HIV primary care Atazanavir: 300 mg taken orally once daily Didanosine: 400 mg taken orally once daily Efavirenz: 600 mg taken orally once daily Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily Lamivudine: 300 mg taken orally once daily Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily Stavudine: Dosage depends on weight Tenofovir disoproxil fumarate: 300 mg taken orally once daily Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.	Delayed-ART n=877 participants at risk Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. (Same drug regimen as that described in the early-ART arm) Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
Musculoskeletal and connective tissue disorders Back pain	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Flank pain	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Hypercreatinaemia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Myalgia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign hydatidiform mole	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Anaemia	1.7% 15/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	2.2% 19/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Anaemia of pregnancy	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Haemolytic anaemia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Iron deficiency anaemia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Leukopenia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Neutropenia	7.0% 62/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	7.5% 66/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Pancytopenia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Blood and lymphatic system disorders Thrombocytopenia	0.68% 6/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.68% 6/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Cardiac disorders Acute coronary syndrome	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Cardiac disorders Cardiac arrest	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Cardiac disorders Cardiac failure	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Cardiac disorders Cor pulmonale	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Cardiac disorders Left ventricular failure	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Cardiac disorders Myocardial infarction	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Cardiac disorders Palpitations	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Congenital, familial and genetic disorders Congenital anomaly in offspring	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Ear and labyrinth disorders Vertigo	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Ear and labyrinth disorders Vertigo positional	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Eye disorders Retinal artery occlusion	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Eye disorders Ulcerative keratitis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Abdominal hernia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Abdominal pain	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.68% 6/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Acute abdomen	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Anal ulcer	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Diarrhoea	1.0% 9/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.80% 7/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.68% 6/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	1.0% 9/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Dyspepsia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Enteritis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Food poisoning	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Gastritis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Haemorrhoids	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Inguinal hernia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Intestinal obstruction	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Mouth ulceration	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Nausea	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Pancreatitis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Peptic ulcer	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Gastrointestinal disorders Vomiting	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Asthenia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Chest pain	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Death	0.79% 7/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Fatigue	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Hyperthermia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Influenza like illness	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Injection site pain	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Multi-organ failure	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Peripheral swelling	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Polyp	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
General disorders Pyrexia	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Cholelithiasis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Drug-induced liver injury	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Hepatic cirrhosis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Hepatic failure	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Hepatitis	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Hepatitis acute	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Hepatitis alcoholic	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Hepatotoxicity	0.68% 6/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Hyperbilirubinaemia	4.2% 37/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	1.6% 14/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Hepatobiliary disorders Liver disorder	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Immune system disorders Anaphylactic reaction	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Immune system disorders Drug hypersensitivity	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Immune system disorders Hypersensitivity	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Abortion infected	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Abscess	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Abscess bacterial	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Acute sinusitis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Appendicitis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Appendicitis perforated	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Bacterial pyelonephritis	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Bacterial sepsis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Bronchitis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Cellulitis	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Cerebral malaria	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Dengue fever	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Diarrhoea infectious	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Disseminated tuberculosis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Dysentery	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Enteritis infectious	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Erysipelas	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Extrapulmonary tuberculosis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.68% 6/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Furuncle	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Gastroenteritis	1.4% 12/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	2.2% 19/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Gastrointestinal infection	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations H1N1 influenza	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Herpes zoster	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Herpes zoster oticus	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Influenza	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Joint abscess	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Leptospirosis	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Liver abscess	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Lower respiratory tract infection	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Lymph node tuberculosis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Malaria	2.6% 23/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	2.3% 20/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Measles	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Meningitis	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Meningitis bacterial	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Meningitis cryptococcal	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Meningitis tuberculous	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Meningococcal sepsis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Meningoencephalitis herpetic	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Muscle abscess	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Nasal abscess	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Nasopharyngitis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Osteomyelitis chronic	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pelvic abscess	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pelvic inflammatory disease	0.90% 8/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.68% 6/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pharyngitis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pharyngitis bacterial	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Plasmodium falciparum infection	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Plasmodium malariae infection	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pneumocystis jirovecii pneumonia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pneumonia	1.8% 16/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	1.3% 11/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pneumonia bacterial	0.79% 7/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pneumonia viral	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Post procedural infection	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Postoperative wound infection	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Progressive multifocal leukoencephalopathy	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pulmonary sepsis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pulmonary tuberculosis	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.80% 7/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pyelonephritis	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Pyelonephritis acute	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Respiratory tract infection	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Secondary syphilis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Sepsis	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Septic shock	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Sinusitis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Subcutaneous abscess	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Tonsillitis	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Tonsillitis bacterial	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Tooth infection	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Tracheobronchitis	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Tuberculosis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Tuberculosis gastrointestinal	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Tuberculous pleurisy	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Tubo-ovarian abscess	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Typhoid fever	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Upper respiratory tract infection	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Urinary tract infection	0.56% 5/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Viral infection	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Viral upper respiratory tract infection	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Infections and infestations Vulval abscess	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Abdominal injury	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Ankle fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Arthropod bite	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Chemical poisoning	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Concussion	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Contusion	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Exposure to toxic agent	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Foot fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Forearm fracture	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Gun shot wound	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Hair injury	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Hand fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Head injury	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Humerus fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Injury	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Joint dislocation	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Joint injury	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Laceration	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Limb injury	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Lower limb fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Overdose	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Poisoning	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Post procedural diarrhoea	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Radius fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Rib fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Skin abrasion	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Skull fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Snake bite	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Spinal compression fracture	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Traumatic haemorrhage	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Injury, poisoning and procedural complications Upper limb fracture	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Alanine aminotransferase increased	2.3% 20/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	2.2% 19/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Aspartate aminotransferase increased	3.6% 32/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	3.3% 29/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood albumin decreased	0.68% 6/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	1.0% 9/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood alkaline phosphatase increased	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood bicarbonate decreased	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood bilirubin increased	7.7% 68/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	4.8% 42/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood cholesterol increased	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood creatinine increased	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.80% 7/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood glucose increased	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood phosphorus decreased	8.2% 73/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	9.8% 86/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood phosphorus increased	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood potassium decreased	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood potassium increased	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood pressure increased	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood sodium decreased	0.90% 8/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.91% 8/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood sodium increased	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Blood triglycerides increased	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Haemoglobin decreased	1.7% 15/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	2.1% 18/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Hepatic enzyme increased	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Liver function test abnormal	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Low density lipoprotein increased	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Neutrophil count decreased	7.2% 64/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	9.1% 80/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Platelet count decreased	0.90% 8/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	2.2% 19/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations Transaminases increased	0.68% 6/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	1.0% 9/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Investigations White blood cell count decreased	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Abnormal loss of weight	8.5% 75/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	6.2% 54/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Decreased appetite	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Diabetes mellitus	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Dyslipidaemia	0.90% 8/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.68% 6/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hypercholesterolaemia	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hyperglycaemia	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hyperkalaemia	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hypernatraemia	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hypoglycaemia	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hyponatraemia	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Hypophosphataemia	4.7% 42/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	4.9% 43/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Obesity	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choriocarcinoma	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phyllodes tumour	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Ataxia	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Central nervous system lesion	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Cerebral atrophy	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Cerebrovascular accident	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Diplegia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Dizziness	1.6% 14/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.91% 8/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Dizziness postural	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Epilepsy	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Febrile convulsion	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Haemorrhagic stroke	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Headache	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.68% 6/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Intracranial venous sinus thrombosis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Loss of consciousness	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Migraine	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Neuropathy peripheral	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Paraplegia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Polyneuropathy	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Seizure	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Somnolence	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Syncope	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Tonic convulsion	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Transient ischaemic attack	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders Tremor	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Nervous system disorders VIIth nerve paralysis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Abortion	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Abortion complete	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.68% 6/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.80% 7/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.0% 9/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	1.8% 16/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Cephalo-pelvic disproportion	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions False labour	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Foetal death	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Placenta praevia	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Acute psychosis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Acute stress disorder	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Aggression	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Anxiety	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Bipolar disorder	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Brief psychotic disorder, with postpartum onset	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Completed suicide	0.56% 5/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Confusional state	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Depressed mood	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Depression	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Drug abuse	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Hallucination	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Homicidal ideation	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Insomnia	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Intentional self-injury	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Major depression	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Mental disorder	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Psychotic disorder	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Suicidal ideation	1.4% 12/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Suicide attempt	0.90% 8/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Psychiatric disorders Violence-related symptom	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Acute kidney injury	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Calculus ureteric	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Chronic kidney disease	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Haematuria	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Hydronephrosis	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Nephrolithiasis	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Nephrotic syndrome	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Renal colic	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Renal failure	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Renal and urinary disorders Urogenital fistula	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Cervical dysplasia	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Dysmenorrhoea	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Erectile dysfunction	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Gynaecomastia	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Menorrhagia	0.45% 4/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Metrorrhagia	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Ovarian cyst	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.23% 2/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Pelvic pain	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Uterine haemorrhage	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Reproductive system and breast disorders Vulvovaginal swelling	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Respiratory, thoracic and mediastinal disorders Asthma	0.23% 2/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.46% 4/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Respiratory, thoracic and mediastinal disorders Pharyngeal mass	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Skin and subcutaneous tissue disorders Lipodystrophy acquired	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Skin and subcutaneous tissue disorders Rash	0.34% 3/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.34% 3/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Skin and subcutaneous tissue disorders Rash generalised	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.00% 0/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Skin and subcutaneous tissue disorders Urticaria	0.11% 1/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Social circumstances Victim of homicide	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Vascular disorders Deep vein thrombosis	0.79% 7/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.57% 5/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Vascular disorders Diabetic vascular disorder	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Vascular disorders Hypertension	0.90% 8/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	1.0% 9/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Vascular disorders Systolic hypertension	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Vascular disorders Thromboangiitis obliterans	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
Vascular disorders Thrombophlebitis superficial	0.00% 0/886 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.	0.11% 1/877 Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Deborah Donnell

Fred Hutchinson Cancer Research Center

Phone: 2066675661

Email: deborah@scharp.org

Results disclosure agreements

• Principal investigator is a sponsor employee All study abstracts and publications are subject to HPTN Publication and Public Information Policies and Clinical Trial Agreements between NIAID (DAIDS) and company collaborators. The publication or other disclosure can be delayed for up to thirty additional business days for manuscripts and five business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER