P4 levels of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.

The success threshold at each analysis corresponded to a nominal p-value <0.0130 to maintain an overall one-sided type I error rate of 0.025.

The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.

The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.

Clinical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.

The success threshold at each analysis corresponded to a nominal p-value <0.0130 to maintain an overall one-sided type I error rate of 0.025.

The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.

The hypotheses was tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.

Biochemical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.

The success threshold at each analysis corresponded to a nominal p-value <0.0130 to maintain an overall one-sided type I error rate of 0.025.

The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.

The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.

LH surge detection of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.

The success threshold at each analysis corresponded to a nominal p-value <0.0130 to maintain an overall one-sided type I error rate of 0.025.

The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.

The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.

Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the Wilcoxon rank sum test without stratification.

Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the Wilcoxon rank sum test without stratification.

Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the Wilcoxon rank sum test without stratification.

Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the Wilcoxon rank sum test without stratification.

Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 21: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 12: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the Wilcoxon rank sum test without stratification.

Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the Wilcoxon rank sum test without stratification.

Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the Wilcoxon rank sum test without stratification.

Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.

Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.

SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.

The p-value was based on the Wilcoxon rank sum test without stratification.

Maximum P4 levels in the LutrePulse 10 µg group were compared to placebo using an analysis of covariance (ANCOVA) model including the randomization scheme and treatment group as factors and baseline value as covariate.

PROC GLM was used for ANCOVA.

p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.

The LSM difference on the treatment groups and 95% confidence interval (CI) for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.

Maximum P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.

PROC GLM was used for ANCOVA.

p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.

The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.

Maximum P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.

PROC GLM was used for ANCOVA.

p-value for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported.

The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.

Mean P4 levels in the LutrePulse 10 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.

PROC GLM was used for ANCOVA.

p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.

The LSM difference on the treatment groups and 95% CI for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.

Mean P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.

PROC GLM was used for ANCOVA.

p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.

The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.

Mean P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.

PROC GLM was used for ANCOVA.

p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.

The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.

The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.

The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.

LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.

The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.

The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.

LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.

The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.

The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.

LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.