Trial Outcomes & Findings for Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED) (NCT NCT00105157)

NCT ID: NCT00105157

Last Updated: 2015-12-04

Results Overview

Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 179 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2015-12-04

Participant Flow

Primary therapy period: 22-Apr-2005 to 09-Nov-2006 Multicenter (31) in the United States (15) and outside the United States (16)

Patients failed prior antiretroviral therapy (HIV RNA >5000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria.

Participant milestones

Measure	MK0518 200 mg b.i.d. Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Double-Blind (DB) STARTED	44	45	45	45
Double-Blind (DB) Treated	43	45	45	45
Double-Blind (DB) COMPLETED	30	31	33	6
Double-Blind (DB) NOT COMPLETED	14	14	12	39
Open-Label Continuation of DB STARTED	30	31	33	6
Open-Label Continuation of DB COMPLETED	23	21	24	5
Open-Label Continuation of DB NOT COMPLETED	7	10	9	1
Open-Label Post Virologic Failure(OLPVF) STARTED	11	13	11	37
Open-Label Post Virologic Failure(OLPVF) COMPLETED	2	7	5	19
Open-Label Post Virologic Failure(OLPVF) NOT COMPLETED	9	6	6	18

Reasons for withdrawal

Measure	MK0518 200 mg b.i.d. Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Double-Blind (DB) Never Treated	1	0	0	0
Double-Blind (DB) Adverse Event	2	0	1	1
Double-Blind (DB) Lack of Efficacy	11	14	11	38
Open-Label Continuation of DB Adverse Event	3	1	0	0
Open-Label Continuation of DB Lack of Efficacy	1	4	3	1
Open-Label Continuation of DB Lost to Follow-up	1	1	1	0
Open-Label Continuation of DB Withdrawal by Subject	0	1	3	0
Open-Label Continuation of DB Patient did not continue in extension	1	0	0	0
Open-Label Continuation of DB Patient moved/site stopped trial	1	3	2	0
Open-Label Post Virologic Failure(OLPVF) Adverse Event	0	0	0	1
Open-Label Post Virologic Failure(OLPVF) Lack of Efficacy	7	6	5	10
Open-Label Post Virologic Failure(OLPVF) Lost to Follow-up	1	0	0	1
Open-Label Post Virologic Failure(OLPVF) Withdrawal by Subject	0	0	0	5
Open-Label Post Virologic Failure(OLPVF) Patient moved/Site stopped trial	1	0	1	1

Baseline Characteristics

Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

Baseline characteristics by cohort

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Total n=178 Participants Total of all reporting groups
Age, Continuous	44.0 years n=5 Participants	45.1 years n=7 Participants	43.8 years n=5 Participants	43.3 years n=4 Participants	44.1 years n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	40 Participants n=7 Participants	41 Participants n=5 Participants	40 Participants n=4 Participants	157 Participants n=21 Participants
Race/Ethnicity, Customized White	36 participants n=5 Participants	35 participants n=7 Participants	32 participants n=5 Participants	33 participants n=4 Participants	136 participants n=21 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	5 participants n=4 Participants	20 participants n=21 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized Hispanic	4 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	5 participants n=4 Participants	18 participants n=21 Participants
Race/Ethnicity, Customized Others	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants
Cluster of Differentiation 4 (CD4) Cell Count	244.9 Cells/mm3 n=5 Participants	220.6 Cells/mm3 n=7 Participants	220.4 Cells/mm3 n=5 Participants	274.0 Cells/mm3 n=4 Participants	239.9 Cells/mm3 n=21 Participants
Plasma HIV RNA	4.6 log10 copies/mL n=5 Participants	4.8 log10 copies/mL n=7 Participants	4.7 log10 copies/mL n=5 Participants	4.7 log10 copies/mL n=4 Participants	4.7 log10 copies/mL n=21 Participants
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)	44642.6 Copies/mL n=5 Participants	59107.9 Copies/mL n=7 Participants	49064.8 Copies/mL n=5 Participants	47432.6 Copies/mL n=4 Participants	49841.6 Copies/mL n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA \<400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy

Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24	-1.80 HIV RNA (log10 copies/mL) Interval -2.1 to -1.5	-1.87 HIV RNA (log10 copies/mL) Interval -2.16 to -1.58	-1.84 HIV RNA (log10 copies/mL) Interval -2.1 to -1.58	-0.35 HIV RNA (log10 copies/mL) Interval -0.61 to -0.09

SECONDARY outcome

Timeframe: 24 weeks

Population: All patients who took study medication and had HIV RNA tests performed were included in the analysis.

Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Virologic Responses at Week 24 HIV RNA <400 copies/mL	30 Participants	32 Participants	32 Participants	7 Participants
Number of Patients With Virologic Responses at Week 24 HIV RNA <50 copies/mL	28 Participants	25 Participants	30 Participants	6 Participants
Number of Patients With Virologic Responses at Week 24 >1.0 log10 Drop in HIV RNA	33 Participants	36 Participants	36 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 Cell Count (cells/mm3) was carried forward for patients who discontinued assigned therapy due to lack of efficacy.

Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Change From Baseline in CD4 Cell Count at Week 24	62.9 CD4 Cell Count (cells/mm3) Interval 27.8 to 97.9	112.8 CD4 Cell Count (cells/mm3) Interval 75.7 to 150.0	94.1 CD4 Cell Count (cells/mm3) Interval 60.1 to 128.0	5.4 CD4 Cell Count (cells/mm3) Interval -9.9 to 20.7

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks With CAEs	37 Participants	37 Participants	41 Participants	37 Participants
Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks Without CAEs	6 Participants	8 Participants	4 Participants	8 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Serious CAEs at 48 Weeks Without Serious CAEs	40 Participants	38 Participants	41 Participants	42 Participants
Number of Patients With Serious CAEs at 48 Weeks With Serious CAEs	3 Participants	7 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Drug-related CAEs at 48 Weeks With Drug-Related CAEs	18 Participants	19 Participants	24 Participants	24 Participants
Number of Patients With Drug-related CAEs at 48 Weeks Without Drug-Related CAEs	25 Participants	26 Participants	21 Participants	21 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Serious Drug-related CAEs at 48 Weeks With Serious Drug-Related CAEs	1 Participants	0 Participants	1 Participants	2 Participants
Number of Patients With Serious Drug-related CAEs at 48 Weeks Without Serious Drug-Related CAEs	42 Participants	45 Participants	44 Participants	43 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Died by 48 Weeks Died	1 Participants	0 Participants	1 Participants	0 Participants
Number of Patients That Died by 48 Weeks Did not Die	42 Participants	45 Participants	44 Participants	45 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With CAEs at 48 Weeks Discontinued With CAEs	1 Participants	0 Participants	1 Participants	1 Participants
Number of Patients That Discontinued With CAEs at 48 Weeks Did Not Discontinue With CAEs	42 Participants	45 Participants	44 Participants	44 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks Discontinued With Drug-related CAEs	0 Participants	0 Participants	0 Participants	1 Participants
Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks Did Not Discontinue With Drug-related CAEs	43 Participants	45 Participants	45 Participants	44 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Serious CAEs at 48 Weeks Discontinued With Serious CAEs	1 Participants	0 Participants	1 Participants	1 Participants
Number of Patients That Discontinued With Serious CAEs at 48 Weeks Did Not Discontinue With Serious CAEs	42 Participants	45 Participants	44 Participants	44 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks Discontinued With Serious Drug-related CAEs	0 Participants	0 Participants	0 Participants	1 Participants
Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks Did Not Discontinue With Serious Drug-related CAEs	43 Participants	45 Participants	45 Participants	44 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks With LAEs	10 Participants	12 Participants	14 Participants	11 Participants
Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks Without LAEs	33 Participants	33 Participants	31 Participants	34 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.

Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Drug-related LAEs at 48 Weeks With Drug-related LAEs	7 Participants	8 Participants	7 Participants	8 Participants
Number of Patients With Drug-related LAEs at 48 Weeks Without Drug-related LAEs	36 Participants	37 Participants	38 Participants	37 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks Discontinued With LAEs	1 Participants	0 Participants	0 Participants	0 Participants
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks Did Not Discontinue With LAEs	42 Participants	45 Participants	45 Participants	45 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients Discontinued With Drug-related LAEs at 48 Weeks Discontinued With Drug-Related LAEs	1 Participants	0 Participants	0 Participants	0 Participants
Number of Patients Discontinued With Drug-related LAEs at 48 Weeks Did Not Discontinue With Drug-Related LAEs	42 Participants	45 Participants	45 Participants	45 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks With CAEs	43 Participants	42 Participants	45 Participants	38 Participants
Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks Without CAEs	0 Participants	3 Participants	0 Participants	7 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Serious CAEs at 96 Weeks With Serious CAEs	4 Participants	9 Participants	5 Participants	3 Participants
Number of Patients With Serious CAEs at 96 Weeks Without Serious CAEs	39 Participants	36 Participants	40 Participants	42 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Drug-related CAEs at 96 Weeks With drug-related CAEs	24 Participants	25 Participants	28 Participants	26 Participants
Number of Patients With Drug-related CAEs at 96 Weeks Without drug-related CAEs	19 Participants	20 Participants	17 Participants	19 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Serious Drug-related CAEs at 96 Weeks With Serious Drug-Related CAEs	1 Participants	0 Participants	1 Participants	2 Participants
Number of Patients With Serious Drug-related CAEs at 96 Weeks Without Serious Drug-Related CAEs	42 Participants	45 Participants	44 Participants	43 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Died by 96 Weeks Died	2 Participants	1 Participants	1 Participants	0 Participants
Number of Patients That Died by 96 Weeks Did Not Die	41 Participants	44 Participants	44 Participants	45 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With CAEs at 96 Weeks Discontinued With CAEs	2 Participants	1 Participants	1 Participants	1 Participants
Number of Patients That Discontinued With CAEs at 96 Weeks Did Not Discontinue With CAEs	41 Participants	44 Participants	44 Participants	44 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks Discontinued With Drug-Related CAEs	0 Participants	0 Participants	0 Participants	1 Participants
Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks Did Not Discontinue With Drug-Related CAEs	43 Participants	45 Participants	45 Participants	44 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Serious CAEs at 96 Weeks Did Not Discontinue With Serious CAEs	41 Participants	44 Participants	44 Participants	44 Participants
Number of Patients That Discontinued With Serious CAEs at 96 Weeks Discontinued With Serious CAEs	2 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks Discontinued With Serious Drug-related CAEs	0 Participants	0 Participants	0 Participants	1 Participants
Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks Did Not Discontinue With Serious Drug-related CAEs	43 Participants	45 Participants	45 Participants	44 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks With LAEs	12 Participants	15 Participants	17 Participants	12 Participants
Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks Without LAEs	31 Participants	30 Participants	28 Participants	33 Participants

SECONDARY outcome

Timeframe: 96 weeks

Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Drug-related LAEs at 96 Weeks With Drug-Related LAEs	9 Participants	9 Participants	11 Participants	8 Participants
Number of Patients With Drug-related LAEs at 96 Weeks Without Drug-Related LAEs	34 Participants	36 Participants	34 Participants	37 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks Discontinued With LAEs	1 Participants	1 Participants	0 Participants	0 Participants
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks Did Not Discontinue With LAEs	42 Participants	44 Participants	45 Participants	45 Participants

SECONDARY outcome

Timeframe: 96 weeks

Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients Discontinued With Drug-related LAEs at 96 Weeks Discontinued With Drug-related LAEs	1 Participants	1 Participants	0 Participants	0 Participants
Number of Patients Discontinued With Drug-related LAEs at 96 Weeks Did Not Discontinue With Drug-related LAEs	42 Participants	44 Participants	45 Participants	45 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks With CAEs	43 Participants	43 Participants	45 Participants	38 Participants
Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks Without CAEs	0 Participants	2 Participants	0 Participants	7 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Serious CAEs at 168 Weeks With Serious CAEs	6 Participants	13 Participants	7 Participants	3 Participants
Number of Patients With Serious CAEs at 168 Weeks Without Serious CAEs	37 Participants	32 Participants	38 Participants	42 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Drug-related CAEs at 168 Weeks With Drug-Related CAEs	27 Participants	27 Participants	30 Participants	26 Participants
Number of Patients With Drug-related CAEs at 168 Weeks Without Drug-Related CAEs	16 Participants	18 Participants	15 Participants	19 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Serious Drug-related CAEs at 168 Weeks With Serious Drug-Related CAEs	2 Participants	0 Participants	2 Participants	2 Participants
Number of Patients With Serious Drug-related CAEs at 168 Weeks Without Serious Drug-Related CAEs	41 Participants	45 Participants	43 Participants	43 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Died by 168 Weeks Died	3 Participants	1 Participants	1 Participants	0 Participants
Number of Patients That Died by 168 Weeks Did not Die	40 Participants	44 Participants	44 Participants	45 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With CAEs at 168 Weeks Discontinued With CAEs	3 Participants	1 Participants	1 Participants	1 Participants
Number of Patients That Discontinued With CAEs at 168 Weeks Did Not Discontinue With CAEs	40 Participants	44 Participants	44 Participants	44 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks Discontinued With Drug-related CAEs	0 Participants	0 Participants	0 Participants	1 Participants
Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks Did Not Discontinue With Drug-related CAEs	43 Participants	45 Participants	45 Participants	44 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Serious CAEs at 168 Weeks Discontinued With Serious CAEs	3 Participants	1 Participants	1 Participants	1 Participants
Number of Patients That Discontinued With Serious CAEs at 168 Weeks Did Not Discontinue With Serious CAEs	40 Participants	44 Participants	44 Participants	44 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks Discontinued With Serious Drug-related CAEs	0 Participants	0 Participants	0 Participants	1 Participants
Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks Did Not Discontinue With Serious Drug-related CAEs	43 Participants	45 Participants	45 Participants	44 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks With LAEs	17 Participants	16 Participants	18 Participants	12 Participants
Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks Without LAEs	26 Participants	29 Participants	27 Participants	33 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Serious LAEs at 168 Weeks With Serious LAEs	1 Participants	0 Participants	1 Participants	0 Participants
Number of Patients With Serious LAEs at 168 Weeks Without Serious LAEs	42 Participants	45 Participants	44 Participants	45 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients Discontinued With Drug-related LAEs at 168 Weeks Discontinued With Drug-Related LAEs	2 Participants	0 Participants	0 Participants	0 Participants
Number of Patients Discontinued With Drug-related LAEs at 168 Weeks Did Not Discontinue With Drug-Related LAEs	41 Participants	45 Participants	45 Participants	45 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Drug-related LAEs at 168 Weeks With Drug-related LAEs	13 Participants	10 Participants	11 Participants	9 Participants
Number of Patients With Drug-related LAEs at 168 Weeks Without Drug-related LAEs	30 Participants	35 Participants	34 Participants	36 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Serious Drug-related LAEs at 168 Weeks With Drug-related LAEs	1 Participants	0 Participants	1 Participants	0 Participants
Number of Patients With Serious Drug-related LAEs at 168 Weeks Without Drug-related LAEs	42 Participants	45 Participants	44 Participants	45 Participants

SECONDARY outcome

Timeframe: 168 weeks

Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients Discontinued With LAEs at 168 Weeks Discontinued With LAEs	2 Participants	0 Participants	0 Participants	0 Participants
Number of Patients Discontinued With LAEs at 168 Weeks Did Not Discontinue With LAEs	41 Participants	45 Participants	45 Participants	45 Participants

POST_HOC outcome

Timeframe: 168 weeks

Population: Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.

Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 168; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 168.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=43 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=43 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=44 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=45 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Number of Patients With Virologic Responses at Week 168 in Combined Substudies HIV RNA <400 copies/mL	21 Participants	15 Participants	22 Participants	5 Participants
Number of Patients With Virologic Responses at Week 168 in Combined Substudies HIV RNA <50 copies/mL	20 Participants	13 Participants	19 Participants	5 Participants
Number of Patients With Virologic Responses at Week 168 in Combined Substudies >1.0 log10 Drop in HIV RNA	22 Participants	15 Participants	23 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 168

Population: Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.

Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=37 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=38 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=40 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=44 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies	-1.67 HIV RNA (log10 copies/mL) Interval -2.17 to -1.18	-1.32 HIV RNA (log10 copies/mL) Interval -1.88 to -0.77	-1.66 HIV RNA (log10 copies/mL) Interval -2.15 to -1.17	-0.33 HIV RNA (log10 copies/mL) Interval -0.61 to -0.04

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 168

Population: Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.

Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.

Outcome measures

Measure	MK0518 200 mg b.i.d. n=36 Participants Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	MK0518 400 mg b.i.d. n=38 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.	MK0518 600 mg b.i.d. n=39 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.	Placebo n=44 Participants OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies	96.9 CD4 Cell Count (cells/mm3) Interval 58.7 to 135.1	107.7 CD4 Cell Count (cells/mm3) Interval 49.4 to 165.9	147.4 CD4 Cell Count (cells/mm3) Interval 86.5 to 208.3	25.5 CD4 Cell Count (cells/mm3) Interval -1.1 to 52.0

Adverse Events

MK0518

Serious events: 28 serious events

Other events: 131 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK0518 n=133 participants at risk Includes patients from the MK0518 200 mg, 400 mg, and 600 mg b.i.d. dose groups. Patients who completed at least 24 weeks of double-blind therapy without virologic failure entered the open-label phase to receive open-label MK0518 400 mg b.i.d.	Placebo n=45 participants at risk OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Vascular disorders Shock	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Blood and lymphatic system disorders Anaemia	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Blood and lymphatic system disorders Lymphadenopathy	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Cardiac disorders Acute Myocardial Infarction	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Cardiac disorders Atrioventricular Block Complete	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Cardiac disorders Bradycardia	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Cardiac disorders Cardio-Respiratory Arrest	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Cardiac disorders Coronary Artery Disease	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Cardiac disorders Myocardial Infarction	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Eye disorders Photophobia	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Anogenital Dysplasia	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Haematemesis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Haematochezia	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Irritable Bowel Syndrome	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Pancreatitis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Pancreatitis Acute	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Varices Oesophageal	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Oedema Peripheral	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Pyrexia	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Hepatobiliary disorders Bile Duct Obstruction	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Hepatobiliary disorders Cholecystitis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Hepatobiliary disorders Portal Hypertension	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Anogenital Warts	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Bronchitis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Cellulitis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Herpes Simplex	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Herpes Zoster	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Leishmaniasis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Pneumonia	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Postoperative Wound Infection	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Sepsis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Splenic Abscess	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Staphylococcal Abscess	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Staphylococcal Infection	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Tracheobronchitis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Injury, poisoning and procedural complications Accidental Overdose	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Injury, poisoning and procedural complications Hip Fracture	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Injury, poisoning and procedural complications Laceration	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Lipase Increased	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Platelet Count Decreased	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Metabolism and nutrition disorders Metabolic Acidosis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer Stage 0	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Disease	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Facial Palsy	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Headache	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Lacunar Infarction	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Renal and urinary disorders Nephrolithiasis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Renal and urinary disorders Renal Failure	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Lipoatrophy	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Rash	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.

Other adverse events

Measure	MK0518 n=133 participants at risk Includes patients from the MK0518 200 mg, 400 mg, and 600 mg b.i.d. dose groups. Patients who completed at least 24 weeks of double-blind therapy without virologic failure entered the open-label phase to receive open-label MK0518 400 mg b.i.d.	Placebo n=45 participants at risk OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Gastrointestinal disorders Nausea	15.8% 21/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	22.2% 10/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Hypoaesthesia Oral	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Gastric Disorder	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Gastritis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Haemorrhoids	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Blood and lymphatic system disorders Anaemia	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Blood and lymphatic system disorders Lymphadenopathy	8.3% 11/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Blood and lymphatic system disorders Splenomegaly	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Cardiac disorders Arrhythmia	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Cardiac disorders Cardiovascular Disorder	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Ear and labyrinth disorders Cerumen Impaction	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Eye disorders Ocular Icterus	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Eye disorders Vision Blurred	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Abdominal Discomfort	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Abdominal Distension	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Abdominal Pain	9.8% 13/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	8.9% 4/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Abdominal Pain Upper	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Anal Fissure	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Anogenital Dysplasia	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Cheilitis	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Constipation	4.5% 6/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Diarrhoea	21.8% 29/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	24.4% 11/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Dry Mouth	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Dyspepsia	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	11.1% 5/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Flatulence	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Periodontitis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Tongue Ulceration	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Toothache	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Gastrointestinal disorders Vomiting	8.3% 11/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Asthenia	4.5% 6/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	6.7% 3/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Chest Discomfort	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Chest Pain	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	6.7% 3/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Chills	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Drug Intolerance	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Fatigue	10.5% 14/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	8.9% 4/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Injection Site Inflammation	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Injection Site Nodule	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Injection Site Reaction	9.0% 12/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	6.7% 3/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Nodule	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Oedema Peripheral	5.3% 7/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Pain	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Pyrexia	9.0% 12/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
General disorders Sensation Of Pressure	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Hepatobiliary disorders Hepatic Steatosis	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Hepatobiliary disorders Hepatosplenomegaly	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Hepatobiliary disorders Hyperbilirubinaemia	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Hepatobiliary disorders Jaundice	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Immune system disorders Drug Hypersensitivity	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Immune system disorders Hypersensitivity	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Acute Tonsillitis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Anogenital Warts	5.3% 7/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Bronchitis	11.3% 15/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	15.6% 7/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Candidiasis	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Cellulitis	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Ear Infection	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Erysipelas	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Folliculitis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Fungal Skin Infection	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Furuncle	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Gastroenteritis	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Genital Herpes	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Giardiasis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Herpes Simplex	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Herpes Virus Infection	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Herpes Zoster	5.3% 7/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Influenza	12.8% 17/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Nasopharyngitis	12.8% 17/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Onychomycosis	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Oral Candidiasis	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Oral Herpes	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Papilloma Viral Infection	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Pharyngitis	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Pharyngotonsillitis	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Pneumonia	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Respiratory Tract Infection	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Sinusitis	5.3% 7/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Sinusitis Bacterial	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Skin Infection	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Syphilis	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Tooth Abscess	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Upper Respiratory Tract Infection	9.8% 13/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	8.9% 4/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Infections and infestations Urinary Tract Infection	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Injury, poisoning and procedural complications Contusion	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Injury, poisoning and procedural complications Excoriation	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Injury, poisoning and procedural complications Skin Laceration	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Alanine Aminotransferase Increased	6.0% 8/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Aspartate Aminotransferase Increased	6.8% 9/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Alkaline Phosphatase Increased	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Amylase Increased	4.5% 6/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Bilirubin Increased	10.5% 14/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Cholesterol Increased	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	8.9% 4/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Creatine Phosphokinase Increased	10.5% 14/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Creatinine Increased	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Glucose Increased	4.5% 6/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Phosphorus Decreased	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Potassium Decreased	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Testosterone Decreased	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Triglycerides Increased	4.5% 6/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Blood Urine Present	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Lipase Increased	5.3% 7/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Low Density Lipoprotein Increased	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Lymphocyte Count Decreased	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Neutrophil Count Decreased	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Platelet Count Decreased	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Protein Urine Present	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations Weight Decreased	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Investigations White Blood Cell Count Decreased	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Metabolism and nutrition disorders Anorexia	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Metabolism and nutrition disorders Decreased Appetite	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Metabolism and nutrition disorders Dyslipidaemia	4.5% 6/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Metabolism and nutrition disorders Hypercholesterolaemia	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 7/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	6.7% 3/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Arthritis	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Back Pain	7.5% 10/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Muscle Hypertrophy	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Muscle Spasms	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	5.3% 7/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Myalgia	6.0% 8/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Neck Pain	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Pain In Extremity	7.5% 10/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Dizziness	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Dysgeusia	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Dysphasia	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Facial Palsy	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Headache	15.8% 21/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	11.1% 5/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Hemicephalalgia	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Hypoaesthesia	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Migraine	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Neuropathy Peripheral	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Paraesthesia	6.0% 8/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Nervous system disorders Syncope	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Psychiatric disorders Anxiety	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Psychiatric disorders Depression	7.5% 10/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Psychiatric disorders Insomnia	9.0% 12/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Psychiatric disorders Sleep Disorder	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Renal and urinary disorders Dysuria	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Renal and urinary disorders Nephrolithiasis	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Renal and urinary disorders Renal Cyst	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Reproductive system and breast disorders Erectile Dysfunction	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Reproductive system and breast disorders Pelvic Pain	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Reproductive system and breast disorders Prostatitis	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Cough	17.3% 23/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.5% 6/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	6.7% 3/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Paranasal Sinus Hypersecretion	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Productive Cough	3.8% 5/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	4.4% 2/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Respiratory, thoracic and mediastinal disorders Sneezing	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Alopecia	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Dyshidrosis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Eczema	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Erythema	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Facial Wasting	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Lipodystrophy Acquired	4.5% 6/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Night Sweats	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	6.7% 3/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Pruritus	6.8% 9/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Rash	6.8% 9/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Rash Macular	0.75% 1/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Rash Papular	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Seborrhoeic Dermatitis	0.00% 0/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Skin Lesion	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Skin Nodule	1.5% 2/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Skin and subcutaneous tissue disorders Subcutaneous Nodule	3.0% 4/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	2.2% 1/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Vascular disorders Hyperaemia	2.3% 3/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.
Vascular disorders Hypertension	9.8% 13/133 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.	0.00% 0/45 • 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively. AEs were assessed by the investigators.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER