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We focused on heterosexual relationships to study the impact of high BMI on sexual health outcomes.
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Figure 1 represents the relationship to study between the dependent and independent variables.
Adverse events were coded with the Medical Dictionary for Regulatory Activities (MedDRA, version 17.0) and classified by date of onset, duration, frequency, severity, and relationship to study medication.
Any adverse event that a subject reported during the study was recorded by the investigators, graded for severity (mild, moderate, or severe), and assessed for its relationship to study treatment (none, possible, probable, or definite).
The AEs were assessed for relationship to study vaccines.
All events were graded by severity and relationship to study treatment [31].
All adverse events were graded for severity and relationship to study product.
Adverse events were classified by severity and potential causal relationship to study drugs.
AEs were graded by severity and relationship to study drug.
Investigators assessed AE severity and relationship to study treatment.
The faecaloma and suicide attempt events were considered to have a definite relationship to study treatment.
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